GenPath Oncology Directory of Services
Transcription
GenPath Oncology Directory of Services
ONE LAB FOR ARRAY CGH FISH TUMOR GENOTYPING FLOW CYTOMETRY HISTOLOGY MOLECULAR GENETICS MORPHOLOGY GenPath Oncology Directory of Services 2014 EDITION CLINICAL GenPath DIRECTORY OF SERVICES 2014 A Business Unit of BioReference Laboratories 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 TEL (800) 627-1479 FAX (201) 791-1941 Visit our website at: www.genpath.com DIRECTORY OF SERVICES 2014 S E C T I O N 1 CONTENTS Letter from Chief Medical Officer....................................................................................................................3 Medical and Scientific Staff..............................................................................................................................4 Laboratory Operations and Service ................................................................................................................4 How to Contact Us............................................................................................................................................5 Supplies..............................................................................................................................................................6 Specimen Preparation....................................................................................................................................13 Specimen Submission Criteria ......................................................................................................................13 Cytology Directions.........................................................................................................................................15 Pathology, Anatomic (Biopsies and Surgical Specimens)...........................................................................16 Specimen Quality and Rejection....................................................................................................................17 Connectivity Solutions....................................................................................................................................18 Test Addition After Submission......................................................................................................................22 AMA Disease-Specific Panels Approved For Government Health Plans......................................................................................................23 Branded Reports.............................................................................................................................................25 Billing Policies and Insurance Coverage.......................................................................................................27 General Billing Information.............................................................................................................................28 List of Insurances for which Bioreference Submits Claims........................................................................29 Licenses and Regulatory Information...........................................................................................................41 How To Use The Test Directory......................................................................................................................42 S E C T I O N 2 - T E S T D I R E C T O R Y Laboratory Tests in Alphabetical Order........................................................................................................ A1 I N D E X Laboratory Tests By Test Name............................................................................................................. B1- B5 Laboratory Tests By Test Code..................................................................................................................... B6 2 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories DIRECTORY OF SERVICES 2014 LETTER FROM CHIEF MEDICAL OFFICER Dear Valued Client, Welcome to the GenPath Oncology Directory of Services for 2014. This directory provides important information that will assist in the test ordering process, including test description and code, clinical indication, and specimen requirements. Our Directory of Services equips you with information on how to contact us, including phone, fax, and e-mail addresses of respective groups in our organization. We also provide you with information on how to effectively work with us, samples of our branded reports, and a background of our billing policies. Please feel free to browse our alphabetical test listing, which includes information on how to submit your specimens for processing, testing methodologies, CPT codes, and clinical indications. GenPath Oncology is a specialized cancer laboratory serving the needs of physicians and patients across the United States. We provide specialized testing services in the following areas: Anatomic and Clinical Pathology, Cytopathology, Dermatopathology, Hematopathology, and Molecular Pathology. If you are unable to find information on a respective test in our Directory of Services, please do not hesitate to call our Customer Service Department at (800) 627–1479. On behalf of all the committed members of GenPath, I look forward to providing your patients with unmatched diagnostic services. Best Regards, James Weisberger, MD Chief Medical Officer 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories 3 DIRECTORY OF SERVICES 2014 MEDICAL AND SCIENTIFIC STAFF Marc D. Grodman, MD President and Chief Executive Officer James D. Weisberger, MD Senior Vice President, Chief Medical Officer, Laboratory Director Ayala Aviram-Goldring, PhD Director, Cytogenetics Katherine Berezowski, MD Medical Director, Cytology — Clarksburg, MD Shiphali Gupta, PhD, FACMG Laboratory Director — Milford, MA Dehui Ku, PhD Director, Special Coagulation Po-Shing Lee, MD Medical Director, Flow Cytometry Annette Meredith, PhD Director, Cancer Genetics Dina Mody, MD Laboratory Director — Houston, TX Karim Oauhchi, MD, FACMG Director, Cytogenetics Kambiz Merati, MD Director, Lenetix Laboratory Luoquan Wang, MD Medical Director, Cytopathology Hashim Othman, PhD Director, Special Chemistry and Toxicology James Sundeen, MD Laboratory Director — Clarksburg, MD Ramana Tantravahi, PhD Assistant Director, Cytogenetics — Milford, MA LABORATORY OPERATIONS AND SERVICE 4 Warren Erdmann Senior Vice President, General Manager Maryanne Amato Vice President, General Manager, GenPath Frank Buccini Director, Molecular Testing Nick Cetani, MS, MT (ASCP) Vice President, Clinical Laboratory Operations Sally Howlett Vice President, Accounts Receivable Karen Muthusammy Director, Client Services Patricia Neybold Director, Core Lab Operations Kathleen Phillips, MPA, MT (ASCP) Director, Quality Systems Estrella Moran Director, Technical Services Ron Rayot Vice President, Director, Logistics Jamie Schwartzmeyer Director, Referral Testing Chris Smith Vice President, Director, Field Operations 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories DIRECTORY OF SERVICES 2014 HOW TO CONTACT US MAIN NUMBER ph: fax: (800) 627-1479 (201) 791-1941 CUSTOMER SERVICE ph: fax: (800) 627-1479 Press 1 (201) 345-7166 LABORATORY SUPPLIES ph: fax: (800) 627-1479 Press 1 (201) 345-7166 SPECIMEN PICK UP ph: fax: (800) 627-1479 Press 3 (201) 791-8878 SALES/MARKETING ph: (800) 627-1479 Press 5 fax: (201) 791-3810 e-mail: [email protected] 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories 5 S U P P L I E S DIRECTORY OF SERVICES 2014 SUPPLIES IMPORTANT REGULATORY NOTICE The Federal Government, through the Centers for Medicare and Medicaid Services (“CMS”), has advised that laboratories may provide items, devices, or supplies if they can be used only to collect, transport, process, or store specimens. If any of these items, devices, or supplies may be used for purposes other than collection, transportation, processing, or storage of specimens, the laboratory may not provide them free of charge. Among the items specifically prohibited by CMS are gloves. With regard to those items that are permitted, such as specimen collection devices (tubes, vials, etc.), needles, tourniquets, needle disposal containers, and refrigerators used solely for the storage of specimens, the laboratory may only provide an amount that is reasonably related to the number of specimens referred to the laboratory by the healthcare provider. New York State law further restricts the types and quantities of supplies that laboratories may offer to healthcare providers. New York permits laboratories to provide, at no charge, only those items, devices or supplies that do not have any generally accepted use in healthcare practices other than to collect, transport, process, or store specimens. Further, these regulations specifically prohibit additional items, such as adhesive bandages, alcohol prep pads, gauze pads, etc. Laboratories must provide permitted supplies, items, and devices of a size, type, and quantity reasonably related to the type and number of specimens being referred by the healthcare provider to the clinical laboratory. Supplies and containers for our laboratory services are provided at no additional charge. These include all blood collection tubes, needles, needle holders, slides, preservative solutions, cytology fixative, and transport boxes and containers specific to the testing type. Supply request forms are available from the lab and should be used to request needed items. Please allow two to three days for delivery of your supplies. 6 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories S U P P L I E S DIRECTORY OF SERVICES 2014 SWABS, VIALS, AND CONTAINERS Sterile Container Viral Culturette (Item #8406): (Item #5493): Plastic wide-mouthed, Sterile swab in transport 5-ounce sterile container with media. Use for routine graduated measure indicator aerobic culturettes from all on side. Supplied with cap. sites. (Squeeze ampule to Use for any culture specimen wet swab with transport (with the exception of urine media). and stool cultures). Aptima Swabs (Item #20671): Used for Chlamydia and Gonorrhea testing (replaces older PACE swabs). Parasitology Kit - Ova and Parasite Collection Vials (Item #20452): Two plastic vials containing PVA and formalin preservative. Inform patient of the importance of the proper sample volume. JEMBEC Plate (Item #1093): Plastic compact container with chocolate agar. Use for Gonorrhea cultures. Urinalysis Tube (Item #10100): Plastic vial with graduated measurement indicator and yellow cap. Stabilizing preservative added (note: may be tablet or coated tube). DO NOT USE FOR URINE CULTURES. Urine Container, for 24-hour Urine Collection: GenProbe Urine Collection (Item #20670): 64-ounce plastic container with handle. Plastic vial with white screw cap. Bacteriostatic preservative present. Use for Chlamydia and Gonorrhea testing. Must specify: No Preservative (Item #8824), HCL (Item #34007), Boric Acid (Item #34006) or Acetic Acid (Item #34020). DO NOT USE FOR ROUTINE URINALYSIS. 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories 7 S U P P L I E S DIRECTORY OF SERVICES 2014 EVACUATED TUBES Light Blue Top (Item #12695): Green Top: Sodium citrate as anticoagulant. Available in 2.7-mL size. This is a siliconized tube containing a citrate solution which is specific for Prothrombin Time and other coagulation tests. Sodium or Ammonium Heparin as anticoagulant. Available in 3-mL (Item #3070) and 6-mL sizes (Item #3051). Grey Top (Item #3172): Lavender Top: Potassium Oxalate as an anticoagulant. Sodium Fluoride as preservative. Available in 6-mL size. EDTA as anticoagulant. Avoid exposure to extreme hot or cold temperatures. Available in 3-mL (Item #7291) and 4-mL sizes (Item #6089). Also available in microtainer sizes for capillary collections. Fresh Tissue Container (Item #13638): One can use these disposable culture tubes for most routine laboratory procedures. Red Top, Plain: Red stopper. No additive. Available in 3-mL (Item #3039) and 10-mL sizes (Item #17483). This tube is used for tests where gel separator is not desirable such as therapeutic drug monitoring. There is no need to centrifuge this tube as it will not remain separated during transport. SST with Clot Activator (Item #6088): This tube is the normal Serum Separator Tube. Please follow these instructions when using the Barrier Tube or the SST Tube with Clot Activator in order to obtain the most accurate test results: 1. Collect blood specimen using the usual venipuncture technique. Fill tube completely. 2. Gently invert barrier tube 5 times to mix clot activator with blood. 3. Allow blood to clot for 30 minutes. 4. Centrifuge at High Speed for 15 minutes. 5. Remove from centrifuge. Barrier will have formed, separating cells from serum. All of the separation gel should have moved from the bottom of the tube to form a barrier layer. 6. The sample is now ready to be transported to the laboratory. Do not remove stopper. 8 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories S U P P L I E S DIRECTORY OF SERVICES 2014 KITS Circulating Tumor Cells Kit (Item #23763): Frozen Coagulation Kit (Item #33042): Includes a CellSave tube that is used to help oncologists in assessing the prognosis of patients with breast, colorectal, or prostate cancer. Used in the diagnosis of acquired or inherited disorders of the coagulation system. Hospital Collection Kit (Item #33029): Bone Marrow Collection Kit (Item #33025): Includes EDTA, heparin, RPMI tubes, slide carrier, and two blocks. Includes two heparin tubes, an EDTA tube, two slide carriers, and two formalin jars (core & clot). Unfrozen Coagulation Kit (Item #33041): Fine Need Aspiration Collection Kit (Item #17515): Used in the diagnosis of acquired or inherited disorders of the coagulation system. Includes two slide carriers each containing five slides, two alcohol filled slide holders and a CytoLyt tube. RPMI Media (Item #G107): Used for the culture of human normal and neoplastic leukocytes. Buffered Formalin (Item # Upon Request) Traditional fixative, buffered to a neutral pH. ThinPrep Cytolyt Collection Cup (Item #18482): Reagent Alcohol 50% (Item #8070): Cellwash and transport buffer for use with the ThinPrep system. For Fine Needle Aspirations. SOLUTIONS 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories 9 S U P P L I E S DIRECTORY OF SERVICES 2014 REQUISITION FORMS 25425 Hema Office Blue 10/12/12 8:41 AM Page 1 PATIENT ID P A T I E N T Final A C C O U N T COMMENTS ENTRIES WILL SHOW ON REPORT ENTRIES WILL SHOW ON REPORT SOCIAL SECURITY NUMBER NAME, LAST (OR CODE NAME) Please Print FIRST STREET AGE M/F APT. # PHONE NO. ( CITY STATE DATE OF BIRTH ) MO DAY YR ZIP COLLECTED DATE TIME AM PM BILLING INFORMATION BILL TO: ■ INSURANCE ■ MEDICARE ■ PATIENT INS. ID # ■ MEDICAID ■ CLIENT GROUP # INSURANCE CARRIER: SUBSCRIBER’S NAME INSURANCE ADDRESS DATE OF BIRTH CITY SECONDARY INSURANCE CARRIER NAME INS. ID # INSURANCE ADDRESS STATE GROUP # ZIP SUBSCRIBER’S NAME CITY HOSPITAL INPATIENT OUTPATIENT NOT A HOSPITAL PATIENT Hematopathology Office Requisition (Item # 25425) REFERRING PHYSICIAN DX CODE __ __ __ __ __ DATE OF BIRTH STATE PATIENT STATUS P H Y S I C I A N S ZIP ALL INSURANCES RELATIONSHIP TO SUBSCRIBER CHILD SELF SPOUSE OTHER _______________ . DX CODE __ __ __ __ __ . DX CODE __ __ __ __ __ DX CODE __ __ __ __ __ . . When ordering tests for Medicare/Medicaid patients, providers should only order tests that are medically necessary for the diagnosis or treatment of a patient, generally not for screening. Only a few screening tests are allowed for certain conditions at specific intervals. ___________________________________________ PHYSICIAN’S SIGNATURE (REQUIRED FOR MEDICAID AND MEDICARE) HEMATOPATHOLOGY OFFICE REQUISITION Form #25425 CLINICAL INFORMATION – attach CBC and Medical History DISEASE STATES UNDER CONSIDERATION Myeloid Neoplasms The Office Requisition is used to order testing for blood-borne cancers. Lymphoproliferative Neoplasms/Plasma Cell Dyscrasias Anemia/leukopenia/thrombocytopenia with negative clinical workup* MDS Essential Thrombocythemia CMML Polycythemia Vera AML (Non-M3) Primary Myelofibrosis APL (AML-M3) Other ____________________________ CML * includes iron studies, B12, folate, reticulocyte count, etc. B-ALL T-ALL MGUS Plasma Cell Myeloma Waldenstöm’s Macroglobulinemia CLL/SLL Mantle Cell Lymphoma Follicular Lymphoma Diffuse Large B-cell Lymphoma Burkitt Lymphoma Hairy Cell Leukemia Marginal Zone Lymphoma/MALT Hodgkin Lymphoma Other ___________________________ TREATMENT STATUS New Diagnosis Follow-up MRD BMT Type Auto Allogenic Sex Mismatched Current Rx: EPO Yes / No G-CSF/CSF Yes / No SPECIMEN INFORMATION Collection Date: ________ Time: _______ Multiple Samples Submitted Yes No Test All Body Site: ______________________________________________________ Blood ______ Green top(s) ______ Lavender top(s) Other: _______________ Bone Marrow: ______ Green top(s)______ Lavender top(s)______ Other: _______________ Slides/Smears: ______ Air dried ______ Unstained ______ Stained Type of stain: ___________________________ Fresh Tissue Site: _________________________ 5500-4 OneCheck™ Hematopathology1 - Guidelines Based Testing. May include any of the testing methodologies listed below. A500-1 OneCheck™ Plus1 GenArray. Includes Array CGH, ONLY if medically necessary, and any of the testing methodologies listed below. BONE MARROW MORPHOLOGY REVIEW Core & Clot in formalin, Smear(s) in slide carrier. May include up to 5 IHC stains. 5199-5 5202-7 Comprehensive Core, Clot & Smears Clot Only 5200-1 Core(s) Only 5211-8 Smears Only 5207-6 Slide Consultation FLOW CYTOMETRY 2mL Heparinized Marrow, 5mL Heparinized Blood or Fresh Tissue in RPMI. 5515-2 Myeloid Lymphoid & Acute Leukemia Analysis 5573-1 Plasma Cell Analysis (Myeloma) A942-5 Residual B-ALL (MRD) 5535-0 5409-8 Lymphoproliferative Analysis If CLL is detected, add ZAP-70 panel ZAP-70 CLL/SLL Prognosis Panel 5155-7 5564-0 Residual (MRD) CLL/SLL Analysis PNH Flaer Panel (Peripheral Blood Only) Other: ________________________________ CYTOGENETICS 5250-6 Chromosome Analysis 2mL Heparinized Marrow (Green Top) for all Disease Types. 5mL Heparinized Blood is Acceptable Only for Acute and Chronic Leukemias. ARRAY COMPARATIVE GENOMIC HYBRIDIZATION 5306-6 (Array CGH) 2mL Marrow in EDTA. Note: GenArray must be ordered in conjunction with Cytogenetics. GenArray Molecular Karyotyping - Bone Marrow Specimen - 2mL 5306-6 GenArray Molecular Karyotyping for CLL - Peripheral Blood - 2mL (EDTA) MOLECULAR GENETICS (FISH/PCR) HEPARIN (Green) EDTA (only) for PCR: 2mL Marrow or 5mL Blood • Na Heparin for FISH: 2mL Marrow or 5mL Blood DISEASE STATE ALL Prognostic Panel AML Comprehensive Diagnostic AML - M1, others AML - M2 AML - M3 (PML/RARA) AML - M4Eo AML - M4 & M5 AML - Prognostic AML - Prognostic AML - Treatment Related Panel CHROMOSOMAL ABERRATIONS t(9;22), 11q23 t(9;22), 11q23, t(8;21), t(15;17), inv(16) t(9;22) t(8;21) t(15;17) inv(16) 11q23 by FISH CEPBA FLT3 & NPM1 +8, -5q, -7q, 20q12 Systemic Mastocytosis (AML Prognosis) c-KIT Chronic Eosinophilic Leukemia CLL Prognostic FISH Panel CLL - IgVH Mutation CML, B-ALL Lymphoma - B - Cell Lymphoma - Burkitt Lymphoma - Diffuse large B-Cell Lymphoma - Follicular Lymphoma - Mantle Cell Lymphoma - Non-Hodgkins Lymphoma - T-Cell MDS Panel MPN - PV, ET, CIMF MPN - ET, CIMF MPN - PV Multiple Myeloma Panel Bone Marrow Transplant Monitoring Hereditary Hemochromatosis PERSONALIZED MEDICINE EDTA (Lavender) FISH P260-3 P261-1 5265-4 5024-5 5260-5 5025-2 5427-0 PCR 5034-4 5261-3 5035-1 8860-9 5988-1 5281-1 FIP1L1-PDGFRA +12, 13q14.3, 17p13, 11q22 IgVH mutation analysis BCR/ABL: t(9;22) IGH MYC/IGH: t(8;14) BCL6: 3q27 BCL2/IGH: t(14;18) BCL1/IGH: t(11;14) BCL1, BCL2, BCL6 TCR +8, -5q, -7q, 20qJAK2 V617F MPL515 mutation analysis (only if JAK2 V617F is negative) JAK2 Exon12 (only if JAK2 V617F is negative) 13q14, t(11;14) & +11, 17p13, t(4;14), 1q21 X/Y C282Y/H63D/S65C 5179-7 5182-1 5280-3 5223-3 5858-6 5278-7 5265-4 5032-8 5027-8 5028-6 5270-4 5026-0 5273-8 5271-2 5031-0 5281-1 5157-3 5272-0 5307-4 5282-9 5066-6 ABL kinase UGT1A1 CYP2D6 DPD, TS, MTHFR 1. May require up to 26 flow cytometry markers, 4 FISH probes, 5 IHC stains and 4 PCR assays. A Business Unit of BioReference Laboratories, Inc. 26474 Oncology Clinical Req:GenPath Oncology Clinical Req 10:00 AM Page 1 Final EDTA (Lavender) 7.5mL in Cell Save Preservative Tube 6237-2 6290-1 5183-9 5287-8 6285-1 PATIENT ID INTERNAL CONTROL (LAB USE ONLY) BLOOD: Green Lavender Other MARROW: Green Lavender Other Slides Core Clot Fresh Block RPMI TISSUE: P A T I E N T LAB I.D. NO. Part 1 - GenPath Laboratories – Part 2 - Client 3/15/11 3420-7 5mL Whole Blood in EDTA. For CTC use Cell Save Tube. Circulating Tumor Cells Imatinib Resistance in CML Irinotecan Toxicity Tamoxifen Efficacy 5-FU - Drug Toxicities 481 EDWARD H. ROSS DR. ELMWOOD PARK, NJ 07407-0621 Tel: 800-627-1479 • Fax: 201-791-8760 Form #25425 (Rev. 10/12) A C C O U N T COMMENTS ENTRIES WILL SHOW ON REPORT ENTRIES WILL SHOW ON REPORT SOCIAL SECURITY NUMBER NAME, LAST (OR CODE NAME) Please Print FIRST STREET AGE M/F APT. # PHONE NO. ( CITY STATE DATE OF BIRTH ) ZIP MO DAY YR COLLECTED DATE AM PM TIME BILLING INFORMATION BILL TO: ■ INSURANCE INS. ID # ■ MEDICARE ■ PATIENT GROUP # SUBSCRIBER’S NAME INSURANCE ADDRESS CITY SECONDARY INSURANCE CARRIER NAME Oncology Clinical Requisition (Item # 26474) The Oncology Clinical Requisition is used to order routine tests necessary for the management of a cancer patient. ONCOLOGY CLINICAL REQUISITION #26474 INSURANCE ADDRESS ALL INSURANCES RELATIONSHIP TO SUBSCRIBER 0053-9 3427-2 3422-3 0286-5 0250-1 0009-1 3320-9 2194-9 3283-9 0400-2 0461-4 0234-5 0580-1 0582-7 0583-5 0360-8 0041-4 0900-1 0516-5 0562-9 0092-7 0342-6 0150-3 0152-9 0153-7 0151-1 GROUP # CITY ■ CHILD ■ SELF 0404-4 (U) 1644-4 (U) 3848-9 (U) DATE OF BIRTH STATE INS. ID # ZIP SUBSCRIBER’S NAME ■ SPOUSE VIRAL Acute Hepatitis Panel CMV Ab, IgG CMV Ab, IgM EBV Capsid Ab, IgG EBV Capsid Ab, IgM EBV, Early Antigen Ab EBV, Nuclear Antigen Ab, IgG HIV 1/O/2 Antibody HORMONES Anti-thyroglobulin Ab Cortisol (random) Estradiol Estrogen Follicle Stimulating Hormone (FSH) Luteinizing Hormone (LH) T3, Total T3 Uptake Thyroid Stimulating Hormone (TSH) Thyroxine ZIP DX CODE DX CODE When ordering tests for Medicare/Medicaid patients, providers should only order tests that are medically necessary for the diagnosis or treatment of a patient, generally not for screening. Only a few screening tests are allowed for certain conditions at specific intervals. ___________________________________________ ■ OTHER _____________________________ CLINICAL INFORMATION PHYSICIAN’S SIGNATURE (REQUIRED FOR MEDICAID) ANEMIA PROFILE 0064-6 Coombs (direct) 0183-4 Erythropoietin 0088-5 Ferritin 0090-1 Folate (Folic Acid) 0514-0 Haptoglobin 0102-4 Hemoglobin A1C (S) 0216-2 Hemoglobin fractionation (HLPC) (S) 0141-2 Reticulocyte Count (S) 0160-2 Vitamin B12 PLASMA CELL MYELOMA 0520-7 (S) Quantitative Immunoglobulins (IgG, IgA, IgM) 0262-6 (S) 1754-1 (U) Beta-2 Microglobulin (L) (S) (S) (S) (S) Protein Electrophoresis Immunofixation Free Kappa & Lambda Light Chain TUMOR MARKERS AFP CA 27.29 CA 125 CEA HCG Quantitative PSA Total PSA Total/Free % REFERRING PHYSICIAN DIAGNOSIS DATE OF BIRTH STATE ROUTINE TESTING CBC with differential platelet count Comprehensive Metabolic Panel Hepatic Function Panel Vitamin D, 25-hydroxy Iron & TIBC 0117-2 LDH CARDIOVASCULAR Basic Lipid Panel (AMA) hs-CRP LDL Direct 0085-1 (S) 0413-5 (S) 3893-5 (S) 0025-7 0823-5 0536-3 0055-4 1201-3 0190-9 2088-3 INSURANCE CARRIER: ■ MEDICAID ■ CLIENT P H Y S I C I A N S (S) (S) (S) (S) (S) (S) (S) (S) (S) (S) (S) (S) (S) (S) (S) (S) (R) (S) (S) (S) (S) (S) (S) (S) (S) (P) (S) (S) (S) (S) (L) (L) (L) (S) MICROBIOLOGY 2665-8 Chlamydia Trachomatis, Amplified DNA (1st Urine) (SC) 2666-6 N. Gonorrhea, Amplified DNA (1st Urine) (SC) 1766-5 H. Pylori, IgA 1765-7 IgG 7736-2 IgM (S) 0079-4 Group A Strep (Throat) (Culturette) Bacterial Culture 0341-8 Blood Culture (2 Bactec) 0080-2 Culture, Urine & Colony Count and Sens (Boricult) 0082-8 Wound, Aerobic Only (Source) ______ URINE TESTING 0359-0 Calcium vol________ (24hr urine) 0072-9 Creatinine Clearance vol________ (24hr urine, S) 0021-6 Citrate vol________ (24hr urine) 8017-6 Electrolytes vol________ (24hr urine) 0444-0 Oxalate vol________ (24hr urine) 0411-9 Phosphorous (Quant) vol________ (24hr urine) 0158-6 Uric Acid vol________ (24hr urine) 0459-8 Urinalysis, routine (w/micros) (U) COLLAGEN VASCULAR DISEASE 0038-0 Antinuclear Antibody (S) 0042-2 ASO Titer (S) 0532-2 Complement factor C3 (S) 0533-0 Complement factor C4 (S) 0375-6 HLA-B27 (L) 0568-6 Lyme Disease Ab (S) 0796-3 Rheumatoid Factor (S) Other Tests: INTERNAL CONTROL (LAB USE ONLY) L-LAV CULTURETTE R-RED S-SST GY-GREY LB-LIGHT BLUE GR-GREEN Y-YELLOW W-PPT RB-ROYAL BL STERILE CUP SC VIRAL CUL O&P BLD. CUL FS-FROZ SPEC SLIDE THINPREP VIAL FORMALIN JAR RAND URN (CUP) PROBE TEC U-URN TUBE TIMED URINE BORBORICULT FOBT T-TAN 24-HOUR URINE M4 BY-BLK & YEL LIPOTUBE 0112-3 Trip 0305-3 Draw Fee vol = _________ 0126-3 NSP – Non-Scheduled Trip GenPath is a business unit of BioReference Laboratories, Inc. 481 EDWARD H. ROSS DR. ELMWOOD PARK, NJ 07407-0621 201-791-8760 • 800-627-1479 10 Part 1 - GenPath Laboratories – Part 2 - Client 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories LAB I.D. NO. Form #26474 (03/11) S U P P L I E S DIRECTORY OF SERVICES 2014 REQUISITION FORMS Final PATIENT ID P A T I E N T COMMENTS ENTRIES WILL SHOW ON REPORT ENTRIES WILL SHOW ON REPORT NAME, LAST (OR CODE NAME) Please Print FIRST STREET CITY STATE RACE/ETHNICITY: r NATIVE AMERICAN r PACIFIC ISLANDER r HISPANIC BILLING INFORMATION BILL TO: r MEDICARE r PATIENT INS. ID # GROUP # r INSURANCE ( MO ZIP r MEDICAID r CLIENT COLLECTED INSURANCE CARRIER: SUBSCRIBER’S NAME DATE OF BIRTH CITY SECONDARY INSURANCE CARRIER NAME STATE INS. ID # INSURANCE ADDRESS GROUP # ZIP STATE r NOT A HOSPITAL PATIENT P H Y S I C I A N S Personalized Medicine Requisition (Item # 20332) REFERRING PHYSICIAN DX CODE __ __ __ . __ __ DX CODE __ __ __ . __ __ DX CODE __ __ __ . __ __ DX CODE __ __ __ . __ __ DATE OF BIRTH When ordering tests for Medicare/Medicaid patients, providers should only order tests SUBSCRIBER’S NAME CITY PATIENT STATUS – ONE MUST BE CHECKED r HOSPITAL INPATIENT r HOSPITAL OUTPATIENT DATE OF BIRTH ) AM DATE TIME PM r ASIAN r AFRICAN-AMERICAN r CAUCASIAN r ASHKENAZI JEWISH r OTHER:______________________________________________________________ INSURANCE ADDRESS that are medically necessary for the diagnosis or treatment of a patient, generally not for screening. Only a few screening tests are allowed for certain conditions at specific intervals. ZIP ___________________________________________ PHYSICIAN’S SIGNATURE (REqUIRED FOR MEDICAID) ALL INSURANCES RELATIONSHIP TO SUBSCRIBER r CHILD r SELF r SPOUSE r OTHER ____________________ SURGICAL # PATIENT I.D. / ROOM NO. ENTRIES IN THIS BOX WILL APPEAR ON REPORT The Personalized Medicine Requisition is used to order molecular testing specific to solid tumors. CLINICAL INFORMATION SPECIMEN INFORMATION Breast Colon Lung Skin Pancreas GI Other Solid Tumor Primary Tumor Site Physician authorizes GenPath to request specimen: Signature Pathology Department Surgical ID# Phone Collection Date Please attach a copy of the pathology report (check the box) Fax COMPREHENSIVE TUMOR GENOTYPING A635-5 Q429-3 OnkoMatch: Genotyping of AKT1, APC, BRAF, CTNNB1, EGFR, IDH1, KIT, KRAS, MAP2K1, NOTCH1, NRAS, PIK3CA, PTEN, TP53 OnkoMatch + for Lung: All 14 cancer genes plus EML4-ALK and c-MET, if ALK negative reflex to ROS1 SINGLE GENE TESTING Lung Colon Individual Tests 5288-6 KRAS B334-4 ROS1 A612-4 c-MET by IHC A300-6 ERCC1 NEW TEST Other 5288-6 KRAS 3371-2 MSI (PCR) A313-9 MLH1 Promoter Methylation* Reflex Testing** B365-8 Reflex Dx: KRAS and MSI (PCR) -> BRAF and MLH1 5891-7 KRAS -> BRAF B366-6 BRAF* –> MLH1 Reflex Testing** B367-4 Reflex Dx: EGFR and KRAS –> ALK –> ROS1 B369-0 EGFR –> ALK –> ROS1 Other: ________________________________________ P264-5 MSI by PCR -> MLH1 Other: _________________________________________ *Useful for detection of Lynch Syndrome, when MSI-H is detected. Please attach MSI result. **With the exception of MSI, ALL reflex testing is completed when the previous result is negative. A Business Unit of BioReference Laboratories, Inc. 5893-3 BRAF 5893-3 BRAF Panel B368-2 KRAS, EGFR, EML4-ALK, ROS1 481 EDWARD H. ROSS DR. ELMWOOD PARK, NJ 07407-0621 TEL: 800-627-1479 Melanoma Individual Tests 5295-1 EGFR A703-1 EML4-ALK FAX completed form, pathology report, and patient insurance to 201-797-0892 Part 1 - GenPath – Part 2 - Client Internal Control (Lab Use Only) BLOOD: Green Lavender MARROW: Green Lavender Other TISSUE: Fresh Block RPMI LAB I.D. NO. Other Form #20332 (06/13) 24413 Antibody Requisition 3/4/13 10:45 AM PATIENT ID P A T I E N T Page 1 Final ENTRIES WILL SHOW ON REPORT NAME, LAST (OR CODE NAME) Please Print FIRST STREET AGE M/F APT. # PHONE NO. ( CITY DATE OF BIRTH ) STATE MO DAY YR ZIP COLLECTED DATE TIME AM PM BILLING INFORMATION Antibody Requisition (Item # 24413) The Antibody Requisition is used by a pathologist to assist in the diagnosis of various cancers. A C C O U N T COMMENTS ENTRIES WILL SHOW ON REPORT SOCIAL SECURITY NUMBER BILL TO: ■ INSURANCE ■ MEDICARE ■ PATIENT INS. ID # ■ MEDICAID ■ CLIENT GROUP # INSURANCE CARRIER: SUBSCRIBER’S NAME INSURANCE ADDRESS CITY SECONDARY INSURANCE CARRIER NAME INSURANCE ADDRESS ANTIBODY REQUISITION Form #24413 PERSONALIZED MEDICINE REQUISITION Form #20332 AGE M/F APT. # PHONE NO. A C C O U N T INS. ID # DATE OF BIRTH STATE GROUP # CITY ZIP SUBSCRIBER’S NAME DATE OF BIRTH STATE ZIP PATIENT STATUS – ONE MUST BE CHECKED ALL INSURANCES RELATIONSHIP TO SUBSCRIBER HOSPITAL INPATIENT OUTPATIENT NOT A HOSPITAL PATIENT CHILD SELF SPOUSE OTHER _______________ P H Y S I C I A N S REFERRING PHYSICIAN DX CODE DX CODE __ __ __ __ __ SURGICAL ID # __ __ __ . . __ __ DX CODE DX CODE __ __ __ __ __ __ . __ __ . __ __ When ordering tests for Medicare/Medicaid patients, providers should only order tests that are medically necessary for the diagnosis or treatment of a patient, generally not for screening. Only a few screening tests are allowed for certain conditions at specific intervals. ___________________________________________ PHYSICIAN’S SIGNATURE (REQUIRED FOR MEDICAID) SPECIMEN INFORMATION ■ Paraffin Block ■ Formalin ■ Other ___________________ Source _______________________________ IMMUNOHISTOCHEMISTRY STAINS ■ With Interpretation ■ Technical Only ■ Digitally Imaged Slides via STORMPATH Antibody ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ A-ACT AAT ACTH Actin (HHF-35) Adenovirus AE1/AE3 AFP ALK-1 Amyloid A Annexin-1 Arginase-1 BCA-225 BCL-2 BCL-6 BerEP4 Beta-Catenin BF-1 BOB-1 CA15.3 CA19.9 CA125 Calcitonin Caldesmon Calponin Calretinin CAM 5.2 Carbonic Anhydrase CD1a CD2 CD3 CD4 CD5 CD7 CD8 Antibody ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ CD10 CD15 CD20 CD21 CD23 CD25 CD30 CD31 CD33 CD34 CD35 CD43 CD44 CD45 CD56 CD57 CD61 CD68 CD79a CD99 CD117 CD123 CD138 CD163 CDX2 CEA monoclonal CEA polyclonal Chromogranin A CK5/6 CK7 CK8 CK 8/18 CK14 CK17 Antibody ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ISH AND CYTOCHEMISTRY STAINS ■ With Interpretation ISH Stains ■ EBER ■ HPV II Low Risk ■ HPV III High Risk ■ Kappa ■ Lambda Cytochemistry Stains ■ Acid fast bacilli (AFB) ■ Alcian Blue ■ Congo Red (amyloid) ■ Elastic ■ Fite’s acid fast stain ■ Giemsa Antibody CK19 CK20 CK903 c-MET CMV Collagen IV COX-2 Cyclin D1 (BCL-1) Desmin DOG-1 EBV (LMP-1) E-Cadherin EGFR EMA EpCAM (MOC31) ER Factor VIIIRA Factor XIIIa Fascin FLI-1 FOXP3 FSH Gastrin GATA-3 GCDFP-15 GFAP GH Glucagon GLUT-1 Glycophorin-A Glypican-3 Granzyme B H. Pylori HBcAg ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ Technical Only ■ Gomori methenamine silver (GMS) ■ Gram stain ■ Hale’s Colloidal Iron ■ Iron ■ Mucicarmine ■ Myeloperoxidase (MPO) Antibody HBME-1 HBsAg HCG HCL Hemoglobin A (Hgb) Hepatocyte Her2neu/c-erb-2 HHV8 HLA-DR HPAP HPL HSV I HSV II IgA IgD IgG IgG4 IgM Inhibin Insulin Kappa Ki-67 Ksp-cadherin Lambda Laminin Lewis Y LH Macrophage (HAM56) Mammaglobin Melan A Melanosome (HMB45) Mesothelin MITF MLH1 ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ Antibody MSH2 MSH6 MUC1 MUC-2 MUC5AC MUC6 MUM-1 Muramidase Myeloperoxidase Myogenin Myoglobin Napsin A NF NSE OCT2 OCT 3/4 p16 p21 p40 p53 p57 p63 p120 Catenin P504S Parvovirus B19 PAX-2 PAX-5 PAX-8 PD1 Perforin PLAP PMS2 Podoplanin PODXL-1 ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ PR Prolactin PSA PSAP/HPAP PSMA PTEN PTH Renal cell S100 SALL4 SMA SMM-HWC Somatostatin Spirochete Surfactant Synaptophysin TAG-72 (B72.3) TCL-1 TdT TFE3 Thrombomodulin Thyroglobulin TIA-1 Toxoplasma TRAP Tryptase TSH TTF1 Tyrosinase Uroplakin Villin Vimentin Wilm’s Tumor (WT-1) ZAP-70 ■ Digitally Imaged Slides via STORMPATH ■ Nonspecific esterase (NSE) ■ PAS (Periodic Acid Schiff) ■ PAS-D (Periodic Acid Schiff with diastase) ■ Reticulin ■ Trichrome ■ Warthin-Starry INTERNAL CONTROL (LAB USE ONLY) SLIDES FRESH TISSUE BLOCK FORMALIN OTHER LAB I.D. NO. A Business Unit of BioReference Laboratories, Inc. 481 EDWARD H. ROSS DR. ELMWOOD PARK, NJ 07407-0621 Tel: 800-627-1479 • Fax: 201-791-8760 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories 02/13 11 S U P P L I E S DIRECTORY OF SERVICES 2014 Final Proof PaTIeNT Id P a T I e N T a c c O U N T cOMMeNTS REQUISITION FORMS eNTrIeS WILL SHOW ON rePOrT eNTrIeS WILL SHOW ON rePOrT NaMe, LaST (Or cOde NaMe) Please Print FIrST STreeT aPT. # PHONe NO. ( cITY STaTe aGe M/F daTe OF BIrTH ) MO daY Yr ZIP cOLLecTed daTe TIMe race/eTHNIcITY: NaTIVe aMerIcaN aSIaN aFrIcaN-aMerIcaN caUcaSIaN aSHKeNaZI JeWISH PacIFIc ISLaNder HISPaNIc OTHer ___________________________ aM PM BIllInG InFOrMATIOn BILL TO: ■ INSUraNce PaTIeNT Id INS. Id # INSUraNce carrIer: ■ MedIcare ■ MedIcaId ■ PaTIeNT ■ cLIeNTcOMMeNTS GrOUP # SUBScrIBer’S NaMe P INSUraNce addreSS cITY a NaMe, LaST (Or cOde NaMe) Please Print SecONdarY INSUraNce carrIer NaMe T PATHOLOGY REQUISITION FOR REQUISITION SOLID TUMORS Form #14030 PATHOLOGY FOR SOLID TUMORS Form #14030 I STreeTaddreSS INSUraNce STaTe INS. Id # cITY daTe OF BIrTH eNTrIeS WILL SHOW ON rePOrT eNTrIeS WILL SHOW ON rePOrT FIrST GrOUP # SUBScrIBer’S NaMe aPT. # PHONe NO. STaTe P H Y S I c I a a N c S c reFerrING PHYSIcIaN O UcOde dX dX cOde dX cOde dX cOde __ __ __ . __ __ __ __ __ . __ __ __ __ __ . __ __ __N__ __ . __ __ When T ordering tests for Medicare/Medicaid patients, providers should only order tests that are Final Proof ZIP medically necessary for the diagnosis or treatment of a patient, generally not for screening. aGe M/F Only P a few screening tests are allowed for certain conditions at specific intervals. daTe OF BIrTH daTeZIP OF BIrTH H ___________________________________________ Y ( ) MO daY Yr S e ZIP cOLLecTed TO SUBScrIBer SUrGIcaL # PATIENT All InsurAnces reLaTIONSHIP N cITY STATUS – ONE MUST BE CHECKEDSTaTe I aM daTe OTHerTIMe cHILd SeLF SPOUSe _________ THOSPITaL INPaTIeNT OuTPaTIeNT nOT a HOSPITaL PaTIeNT race/eTHNIcITY: NaTIVe aMerIcaN aSIaN aFrIcaN-aMerIcaN caUcaSIaN aSHKeNaZI JeWISH PacIFIc ISLaNder HISPaNIc OTHer ___________________________ clInIcAl InFOrMATIOn BIllInG InFOrMATIOn BILL TO: ■ Slides ■ INSUraNce ■ Fresh INS. Id # Tissue sPecIMen InFOrMATIOn PM c I a N S PHYSIcIaN’S SIGNaTUre (reqUIred FOr MedIcaId) PaTIeNT I.d. / rOOM NO. eNTrIeS IN THIS BOX WILL aPPear ON rePOrT Solid Tumor Requisition (Item # 14030) The Solid Tumor Requisition is used by a pathologist primarily to assist in the diagnosis of solid tumors. reFerrING PHYSIcIaN carrIer: ■ ____ MedIcare air dried■ MedIcaId ____ StainedINSUraNce ____ Unstained ____ Type of stain: ____________ ■ Paraffin Block ■ Formalin ■ B5 ■ Other: ___________ ■ PaTIeNT ■ cLIeNT Site: _______________________ BodyNaMe Site ■ Breast ■ colorectal daTe ■ Lung Prostate ■ Liver ■ Other: _____________________________ cOde dX cOde dX cOde dX cOde GrOUP # SUBScrIBer’S OF BIrTH■ dX INSUraNce addreSS BreAsT cITY . __ __ __ __ __ . __ __ __ __ __ . __ __ IMMunOHIsTOcHeMIsTrY __ __ __ STaTe ZIP __ __ __ . __ __ When ordering tests for Medicare/Medicaid patients, providers should only order tests that are ASCO/CAP Guidelines (Only FFPE Blocks are acceptable for evaluation) With Interp Tech Onlymedically necessary for the diagnosis or treatment of a patient, generally not for screening. Only a few screening tests are allowed for certain conditions at specific intervals. 1. Fixation time ____________________ 2. cold Time ____________________ ■ a130-7 ■ Lung carcinoma: adenocarcinoma vs. Squamous SecONdarY INSUraNce carrIer NaMe INS.Ischemia Id # GrOUP # SUBScrIBer’S NaMe daTe OF BIrTH With Interp Tech Only ■ a612-4 ■ c-MeT by IHc ___________________________________________ ■ 5176-3 addreSS ■ a952-4 Breast carcinoma,cITY r/O Microinvasion ■ a972-2 ZIP ■ Her2 by IHc in Gastric/Gastroesophageal carcinoma INSUraNce STaTe PHYSIcIaN’S SIGNaTUre (reqUIred FOr MedIcaId) ■ 5198-7 ■ 5425-4 er/Pr ■ 5175-5 ■ GIST Profile PaTIeNT I.d. / rOOM NO. PATIENT STATUS MUST BE CHECKED All InsurAnces reLaTIONSHIP TO SUBScrIBer ■ 5161-5 ■ 5127-6 – ONE er/Pr/Her2 ■ 3412-4 ■ SUrGIcaL HPV# High/Low risk by ISH HOSPITaL OuTPaTIeNT nOT a HOSPITaL PaTIeNT cHILd SeLF SPOUSe ■OTHer _________ ■ HPVeNTrIeS High riskINbyTHIS ISH BOX WILL aPPear ON rePOrT ■ 5163-1 INPaTIeNT ■ 5433-8 er/Pr/Ki-67/Her2 8714-8 ■ a943-3 ■ Mismatch repair Protein (MMr) for Lynch Syndrome ■ a954-0 ■ a951-6 er/Pr/Ki-67/Her2/p53 clInIcAl InFOrMATIOn ■ 5195-3 ■ Neuroendocrine Neoplasm Profile ■ 5428-8 N/a Her2 IHc - reflex 2+ to Her2 by FISH ■ 5103-7 ■ NHL vs. reactive Hyperplasia, Lymphoma Panel ■ 5406-4 N/a er/Pr/Her2 - reflex 2+ to Her2 by FISH sPecIMen InFOrMATIOn ■ 5111-0 N/a Pathology Slide consultation (interpretation only) ■ 5575-6 N/a dNa Ploidy ■ 5097-1 ■ ProstateBlock cancer ■ Profile (cK903, ■ Slides 5152-4 ■ a346-9____ Ki-67 ■ air dried ____ Stained ____ Unstained ____ Type of stain: ____________ ■ Paraffin Formalin ■ p63, B5 P504S) ■ Other: ___________ ■ 5191-2■ Lung ■ ■ Prostate Spindle■cell Neoplasm Profile ■ Fresh 5171-4Tissue ■ 5405-6Site: _______________________ Her2 by IHc ■ Body Site ■ Breast ■ colorectal Liver ■ Other: _____________________________ ■ 5190-4 ■ Tumor of Unknown Primary ■ 5262-1 ■ 5259-7 Her2 by FISH BreAsT IMMunOHIsTOcHeMIsTrY Other: ■ All Breast slides will be digitally imaged unless checked here ■ Check digitally image TC Only slides via STORMPATH ASCO/CAP Guidelines (Only FFPE Blocks are acceptable for evaluation) With Interphere TechtoOnly FIsH MOleculAr/TArGeTeD THerAPY ■ a130-7 ■ Lung carcinoma: adenocarcinoma vs. Squamous ■ a612-4 ■ c-MeT by IHc Tumor Genotyping NEW TEST ■ ■ Her2Genotyping by IHc in Gastric/Gastroesophageal ■ a972-2 a635-5 OnkoMatch: Tumor of 14 cancer Genes (3) carcinoma ■ ■ GIST Profile ■ 5175-5 a642-1 OnkoMatch + for Lung: 14 cancer Genes with eML4-aLK and c-MeT by IHc ■ 3412-4 ■ reflex HPV High/Low risk by ISH ■ If aLK negative, to rOS1 ■ 8714-8 ■ HPV High risk by ISH lung ■ a943-3 Tests ■ Mismatch repair Protein (MMr) for Lynch Syndrome Individual OTHer ■ 5428-8 N/a Her2 IHc - reflex 2+ to Her2 by FISH ■ ■ Neuroendocrine Neoplasm Profile ■ 5195-3 5295-1 eGFr ■ 5406-4 N/a er/Pr/Her2 ■ ■ NHL vs. reactive■Hyperplasia, Lymphoma Panel With Interpretation ■ Technical Only - reflex 2+ to Her2 by FISH ■ 5103-7 a703-1 eML4-aLK B236-1 Tech Only ■ 5575-6 N/a dNa Ploidy ■ N/aby FISHPathology Slide consultation (interpretation only) ■ 5111-0 B334-4 rOS1 with Interp ■ B337-7 Tech Only NEW TEST ■ 5152-4 ■ a346-9 Ki-67 ■ ■ Prostate cancer Profile (cK903, p63, P504S) ■ 5097-1 a300-6 ercc1 ■ 5171-4 ■ 5405-6 Her2 by IHc ■ 5191-2 ■ Spindle cell Neoplasm Profile Panel ■ 5262-1 ■ 5259-7 Her2 by FISH ■ 5190-4 ■ Tumor of Unknown Primary ■ B368-2 Lung Panel: KraS, eGFr, eML4-aLK, rOS1 ■ All Breast slides will be digitally imaged unless checked here Other: reflex Testing ■ Check here to digitally image TC Only slides via STORMPATH FIsH ■ B367-4 reflex dx: adenocarcinoma: eGFr and KraS -> aLK -> rOS1 MOleculAr/TArGeTeD THerAPY eGFr -> aLK -> rOS1 ■ 5324-9 ■ 5253-0 comprehensive Urine Pathology (UroVysion and Urine cytology)(1) ■ B369-0 Tumor colon Genotyping NEW TEST ■ 5030-2 ■ 5249-8 UroVysion (1) Individual ■ a427-7 ■ a428-5 Her2 by FISH in Gastric/Gastroesophageal carcinoma ■ a635-5 Tests OnkoMatch: Tumor Genotyping of 14 cancer Genes (3) notes: 3371-2 Microsatellite Instability Pcr Genes (MSI) with eML4-aLK and c-MeT by IHc (1) Urine specimen in ThinPrep preservative (cytolyt) or carbowax ■ a642-1 OnkoMatch + for Lung: 14by cancer MOlAr PreGnAncY (2) p57 is always Global when ordered with dNa Ploidy ■■ a313-9 MLH1 Promoter (for Microsatellite Instable tumors) (4) If aLK negative, reflex to Methylation rOS1 ■ 5555-8 N/a dNa Ploidy for Molar Pregnancy (3) Includes aKT1, aPc, BraF, cTNNB1, eGFr, IdH1, KIT, KraS, MaP2K1, NOTcH1, NraS, PIK3ca, reflex Testing lung ■PTeN, 5550-9 dNa Ploidy for Molar Pregnancy + p57 (2) Both Global TP53 N/a ■ B365-8 Tests reflex dx: colon: KraS and MSI -> BraF and MLH1 Individual (4) Please attach MSI result report when sending in OTHer specimen 5891-7 KraS -> BraF ■ 5295-1 eGFr ■ With Interpretation ■ Technical Only B366-6 Lynch Syndrome: BraF -> MLH1 (for Microsatellite Instable tumors) (4) ■ a703-1 eML4-aLK ■ B236-1 Tech Only Multiple Types ■ B334-4Tumor rOS1 by FISH with Interp ■ B337-7 Tech Only NEW TEST 5288-6 KraS ■ a300-6 ercc1 ■ 5893-3 BraF Panel a344-4 c-KIT/PdGFra (GIST) for Imatinib resistance ■ B368-2 Lung Panel: KraS, eGFr, eML4-aLK, rOS1 (Gastric only) 1. ____________________ cold Ischemia(UroVysion Time ____________________ ■ Fixation 5324-9 time ■ 5253-0 comprehensive2. Urine Pathology and Urine cytology)(1) With Interp Tech Only ■ 5030-2 ■ 5249-8 UroVysion (1) ■ ■ Breast carcinoma, r/O Microinvasion ■ 5176-3 a427-7 ■ a952-4 a428-5 Her2 by FISH in Gastric/Gastroesophageal carcinoma ■ 5198-7 ■ 5425-4 er/Pr MOlAr PreGnAncY ■ 5161-5 ■ 5127-6 er/Pr/Her2 ■ 5163-1 5555-8 N/a dNa Ploidy for Molar Pregnancy ■ ■ 5433-8 er/Pr/Ki-67/Her2 ■ a954-0 5550-9 N/a dNa Ploidy for Molar Pregnancy + p57 (2) Both Global ■ ■ a951-6 er/Pr/Ki-67/Her2/p53 reflex Testing InTernAl cOnTrOl (lAB use OnlY) ■ B367-4 reflex dx: adenocarcinoma: eGFr and KraS -> aLK -> rOS1 notes: (1) Urine specimen in ThinPrep preservative (cytolyt) or carbowax (2) p57 is always Global when ordered with dNa Ploidy (3) Includes aKT1, aPc, BraF, cTNNB1, eGFr, IdH1, KIT, KraS, MaP2K1, NOTcH1, NraS, PIK3ca, PTeN, TP53 (4) Please attach MSI result report when sending in specimen see BAcK FOr ■ B369-0 eGFr -> aLK -> rOS1 cOMPleTe PAnel lIsTInG colon AnDTests cOMPOnenTs Individual slIDes FresH TIssue BlOcK FOrMaLIN ■ 3371-2 Microsatellite Instability by Pcr (MSI)OTHer ■ a313-9 MLH1 Promoter Methylation (for Microsatellite Instable tumors) (4) LaB I.d. NO. reflex Testing ■ B365-8 reflex dx: colon: KraS and MSI -> BraF and MLH1 ■ 5891-7 KraS -> BraF ■ B366-6 Lynch Syndrome: BraF -> MLH1 (for Microsatellite Instable tumors) (4) Multiple Tumor Types ■ 5288-6 KraS ■ 5893-3 BraF ■ a344-4 c-KIT/PdGFra (GIST) for Imatinib resistance (Gastric only) InTernAl cOnTrOl (lAB use OnlY) see BAcK FOr cOMPleTe PAnel lIsTInG AnD cOMPOnenTs A Business Unit of BioReference Laboratories, Inc. 481 eDWArD H. rOss Dr. elMWOOD PArK, nJ 07407-0621 Tel: 800-627-1479 • FAX: 201-791-8760 slIDes FresH TIssue BlOcK FOrMaLIN 20920 Special Coagulation Req. OTHer 2:25 PM Page 1 Final Form #14030 06/13 PATIENT ID P A T I E N T A Business Unit of BioReference Laboratories, Inc. Special Coagulation Requisition (Item # 20920) The Special Coagulation Requisition is used to order diagnostic testing for acquired or inherited disorders of the coagulation system. Form #14030 06/13 COMMENTS ENTRIES WILL SHOW ON REPORT NAME, LAST (OR CODE NAME) Please Print FIRST STREET AGE M/F APT. # PHONE NO. ( CITY DATE OF BIRTH ) STATE MO DAY YR ZIP COLLECTED AM PM DATE TIME RACE/ETHNICITY: NATIVE AMERICAN ASIAN AFRICAN-AMERICAN CAUCASIAN ASHKENAZI JEWISH PACIFIC ISLANDER HISPANIC OTHER ___________________________ BILLING INFORMATION BILL TO: ■ INSURANCE ■ MEDICARE ■ PATIENT INS. ID # ■ MEDICAID ■ CLIENT GROUP # INSURANCE ADDRESS SECONDARY INSURANCE CARRIER NAME SPECIAL COAGULATION REQUISITION Form #20920 481 eDWArD H. rOss Dr. elMWOOD PArK, nJ 07407-0621 Tel: 800-627-1479 • FAX: 201-791-8760 3/4/13 LaB I.d. NO. INSURANCE ADDRESS INSURANCE CARRIER: SUBSCRIBER’S NAME DATE OF BIRTH CITY STATE INS. ID # GROUP # SUBSCRIBER’S NAME CITY ZIP DATE OF BIRTH STATE ALL INSURANCES RELATION TO SUBSCRIBER CHILD SELF SPOUSE ZIP A C C O U N T P H Y S I C I A N S DX CODE DX CODE DX CODE DX CODE __ __ __ __ __ DX CODE __ __ __ __ __ __ __ __ __ __ DX CODE __ __ __ __ __ __ __ __ __ __ DX CODE __ __ __ __ __ __ __ __ __ __ DX CODE __ __ __ __ __ . . . . . . . . When ordering tests for Medicare/Medicaid patients, providers should only order tests that are medically necessary for the diagnosis or treatment of a patient. A few tests for screening (certain conditions at specific intervals) are allowed. ___________________________________________ OTHER PHYSICIAN’S SIGNATURE (REQUIRED FOR MEDICAID) PATIENT HISTORY Patient History (comprehensive information assists in efficient interpretation of lab results): ______________________________________________________________________ _____________________________________________________________________________________________________________________________________________________ Previous History of Thrombosis: Venous Arterial Thrombosis TIA Stroke MI Past History of Bleeding: Yes No Plavix® Other Anti-Thrombotic Agents ____________ Current Anticoagulation: Aspirin Anti-Platelet Drug Coumadin® Surgery Expected Date of Surgery ________________________ PANELS - Individual tests should be ordered for Medicare/Medicaid patients. See reverse. ■ Check this box for a comprehensive interpretation of the submitted case. 6800-7 ■ General Thrombophilia Assessment for Inherited & Acquired Disorders† 6801-5 ■ Pregnancy Thrombophilia Assessment† 6802-3 ■ Arterial & Atherothrombotic Risk – Expanded† † Requires a Patient Informed Consent. See Inherited DNA Mutation Test section below. Code 5705-9 ■ 5704-2 ■ 5709-1 ■ 5706-7 ■ 5710-9 ■ 5720-8 ■ 5722-4 ■ 5790-1 ■ 5820-6 ■ 5702-6 ■ 5703-4 ■ 5714-1 ■ 5723-2 ■ 5715-8 ■ 5717-4 ■ 5780-2 ■ 5744-8 ■ 5719-0 ■ 5743-0 ■ 5730-7 ■ 5770-3 ■ 5724-0 ■ 5725-7 ■ 5728-1 ■ 5729-9 ■ 5851-1 ■ 5853-7 ■ 5852-9 ■ 5817-2 ■ 5994-9 ■ 5990-7 ■ 5874-3 ■ 5997-2 ■ Test Name Specimen Activated Protein C Resistance (APCR, M) FP Activated Protein C Resistance (APCR, S) FP Alpha2 Antiplasmin FP Anti-Annexin V (5) Antibodies (IgG, IgM) FS Anti-Beta2 Glycoprotein 1 (lgG, IgM, IgA) FS Anti-Cardiolipin Abs (IgG, IgM, IgA) (Antiphospholipid Ab) FS Anti-Phosphatidyl Ethanolamine Antibodies (IgG, IgM) FS Anti-Phosphatidylserine Antibodies (IgG, IgM) FS Anti-Prothrombin Antibodies (IgG, IgM) FS Antiplatelet Antibody - Direct WB (10-15 mL) Antiplatelet Antibody - Indirect FS Antithrombin Activity (ATIll Activity) - Thrombin Based FP Antithrombin Activity (ATIII Activity) - Anti-Xa Based FP Antithrombin Antigen FP C4b Binding Protein (C4b-BP) FP CBC, w/Diff & Platelets WB Collagen Binding Assay (vWF CBA) FP C-Reactive Protein-HS FS D-Dimer, Quantitative FP dRVVT - Complete FP Euglobulin Clot Lysis FP Factor II (2) Clotting Activity (Prothrombin Level) FP Factor V (5) Clotting Activity FP Factor VII (7) Clotting Activity FP Factor VIII (8) Clotting Activity FP Abnormal aPTT Assessment Abnormal PT & aPTT Assessment Abnormal PT Solely Lupus Inhibitor Screen Antiphospholipid Antibody & Lupus Inhibitor Assessment – Basic Antiphospholipid Antibody & Lupus Inhibitor Assessment – Expanded Arterial & Atherothrombotic Risk – Basic Bleeding Diathesis Evaluation Code 5769-5 ■ 5736-4 ■ 5707-5 ■ 5735-6 ■ 5737-2 ■ 5738-0 ■ 5739-8 ■ 5824-8 ■ 5745-5 ■ 5748-9 ■ 5761-2 ■ 5746-3 ■ 5749-7 ■ 5754-7 ■ 5755-4 ■ 5757-0 ■ 5157-3 ■ 5307-4 ■ 5758-8 ■ 5830-5 ■ 5840-4 ■ 5771-1 ■ 5835-4 ■ 5774-5 ■ INDIVIDUAL TESTS Test Name Factor IX (9) Clotting Activity Factor X (10) Antigen Factor X (10) Chromogenic Factor X (10) Clotting Activity Factor XI (11) Clotting Activity Factor XII (12) Clotting Activity Factor XIII (13) Activity Fibrin Monomer Fibrinogen Clottable Activity Heparin Cofactor II Heparin Level (Anti-Xa) Heparin Platelet Antibody (HIT) by ELISA Hexagonal Phase Assay STACLOT LA HMW Kininogen (Fitzgerald Factor) Homocysteine Inhibitor Titer (Quantitative Bethesda Unit) JAK-2 V617F Mutation Analysis JAK-2 Exon 12 Mutation Analysis (only run if Specimen FP FP FP FP FP FP FP FP FP FP FP FS FP FP FS FP WB WB JAK2-V617F is Negative) Lipoprotein a, Lp(a) Mixing Study – aPTT Mixing Study – PT Partial Thromboplastin Time (aPTT) Lupus Sensitive Partial Thromboplastin (aPTT) Standard Plasminogen Activator Inhibitor Activity (PAI-1) FS FP FP FP FP FP INHERITED DNA MUTATION TESTS – Requires Patient Informed Consent Form 5992-3 ■ 5860-2 ■ 5818-0 ■ 5993-1 ■ 5989-9 ■ 5825-5 ■ 5826-3 ■ Code 5775-2 ■ 5777-8 ■ 5778-6 ■ 5784-4 ■ 5779-4 ■ 5741-4 ■ 5742-2 ■ 5786-9 ■ 5785-1 ■ 5787-7 ■ 5788-5 ■ 5789-3 ■ 5759-6 ■ 5797-6 ■ 5798-4 ■ 5799-2 ■ 5805-7 ■ 5806-5 ■ 5753-9 ■ 5807-3 ■ 5808-1 ■ 5823-0 ■ 5815-6 ■ 5816-4 ■ DIC Assessment Fibrinolytic Evaluation – Standard For Specific Factor Inhibitor Hyperactive Coagulation Panel Venous Prothrombotic Risk Factor von Willebrand Screen - Basic von Willebrand Screen - Expanded Test Name Specimen Plasminogen Activity (Chromogenic) FP Platelet Count WB Platelet Size Analysis-Smear analysis WB Platelet Neutralizing Procedure (PNP) FP Prekallikrein (Fletcher Factor) Clotting Activity FP Protease Activity for vWF (ADAMTS13) FP Protease Inhibitor Assay for vWF (ADAMTS13 Ab) FP Protein C Antigen FP Protein C Chromogenic Activity FP Protein S Activity – Clotting FP Protein S Antigen – Free FP Protein S Antigen – Total FP Protein Z Antigen FP Prothrombin Fragment 1.2 (F1.2) FP Prothrombin Time (PT) FP Reptilase Time FP Ristocetin Cofactor, vWF Activity (vWF:RCoF) FP Ristocetin Induced Platelet Aggregation (RIPA)* FP Smear Review (Morphology) WB Thrombin Time (TT) FP Thrombin/Antithrombin Complex (TAT) FP von Willebrand’s Normandy Assay** FP von Willebrand’s Factor Antigen (vWF:Ag) FP vWF Multimers*** FP INTERNAL CONTROL (LAB USE ONLY) Patient has signed an Informed Consent form regarding the inherited genetic tests below. Physician Signature & UPIN # ___________________________________________________________________ 5726-5 ■ 5765-3 ■ 5764-6 ■ 5768-7 ■ Factor V (5) Leiden Mutation (FVL) MTHFR (A1298C) Mutation MTHFR (C677T) Mutation PAI 4G/5G Polymorphism WB-LAV WB-LAV WB-LAV WB-LAV 5847-9 ■ Plavix Resistance (CYP2C19) 5795-0 ■ Prothrombin (G20210A) Mutation 6261-2 ■ Warfarin Pharmacogenetics WB-LAV WB-LAV WB-LAV Note: Patient Consent for Inherited DNA Mutation tests required in Arizona, Florida, Georgia, Massachusetts, Michigan, Nebraska, New Mexico, New York, South Carolina, South Dakota, and Vermont. 481 EDWARD H ROSS DRIVE ELMWOOD PARK, NJ 07407-0621 TEL: 800-627-1479 • FAX: 201-791-8760 12 *5806-5 is from frozen plasma only. **5823-0 von Willebrand’s Normandy Assay - If FVIII is ≥40%, we will not perform this test. ***5816-4 vWF Multimers will only be performed if any of the following criteria are met: 1. vWF:AG is <50% and vWF:Rcof activity is <40%. 2. If the vWF antigen is 2.5 folds higher than the vWF:Rcof. 3. vwF antigen level is normal and the vWF:Rcof activity is abnormal. L-LAV R-RED S-SST BL-BLUE FROZ PLASMA FROZ SERUM RAND URN (CUP) U-URN TUBE Y YELLOW SLIDE LAB I.D. NO. Specimen Key FP = Aliquoted Frozen Plasma (Blue top tube) WB = Whole Blood, Lavender top tube, Room Temperature PP = Requires Patient’s Presence FS = Aliquoted Frozen Serum (SST/Red top tube) 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories Form #20920 (Rev. 3/13) S P E C I M E N P R E P A R A T I O N DIRECTORY OF SERVICES 2014 SPECIMEN PREPARATION SPECIMEN LABELING ALL SPECIMENS MAY BE POTENTIALLY INFECTIOUS MATERIAL AND SHOULD BE HANDLED, LABELED, AND TRANSPORTED ACCORDINGLY. It is essential that the following instructions be followed exactly to assure delivery of a specimen that is adequate for testing. All specimens must be properly identified by using a minimum of two identifiers that must include the patient’s name and at least one of the following: date of birth, chart number or a unique identifier. Also, the phlebotomist must initial all specimen containers submitted. The test request form must be completed and include the time and date of the specimen collection, as well as the signature of the physician, or other legally-authorized person requesting the patient’s tests. PROPER PHLEBOTOMY TECHNIQUES 1. Fill tubes to capacity required level 2. Mix gently 3. Separate Always make sure to collect enough specimen. Immediately following collection, all plastic tubes require mixing. Gently invert all tubes eight (8) times, except Light Blue Tubes (invert 4 times). Do not use Gel Tubes (Red/Black SST®) for toxicology or therapeutic drug testing. SPECIMEN SUBMISSION CRITERIA Blood When whole blood is requested, obtain the full amount in a vacuum tube as shown in the Specimen Preparation section of this Directory of Services. Lavender, Grey, Green, Yellow, Tan, and Royal Blue Top tubes contain different anticoagulants that inhibit blood coagulation. When drawing these specimens, immediately invert the tube 8-10 times. Invert Light Blue Top Tubes 3-4 times. Do not shake the tube, as this can cause hemolysis. 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories 13 S P E C I M E N P R E P A R A T I O N DIRECTORY OF SERVICES 2014 Serum Obtain sufficient blood to yield the required volume of serum. A plain Red Top tube or Red/ Speckled Top Barrier Gel Tube (SST) should be used. (Refer to Test Section for details.) When drawing these specimens, immediately invert the tube eight (8) times. Allow the blood to clot for no more than 30 minutes and centrifuge for 15 minutes to separate the serum at 31353465 rpms (4500-5000 rpms for coagulation testing). If a Barrier Gel Tube is used, no other manipulations are required. Make sure that the gel has formed a thick, solid, intact barrier between the serum and the clotted cells. If the gel trails into the bottom of the tube, re-centrifuge the tube for another 10 minutes. If a plain Red Top Tube is used, transfer the serum with a pipette to a Transfer Tube. It is important to avoid hemolysis. Serum in contact with red cells will produce erroneously high Potassium, LD, AST, and ALT results and erroneously low Glucose results. Label Transfer Tube with patient’s full name, identifiers and specimen type (e.g. serum, plasma, etc). Plasma When processing plasma, follow the instructions for each test. Urine Urinalysis: To adequately test urine specimens the sample should be collected in a tube with a stabilizing chemical present. The tube provided contains a yellow “pop off” cap and a “Stabilur®” tablet or coated tube that preserves the formed elements such as red cells, white cells, casts, and epithelial cells. For urinalysis, use a paper cup and transfer about 10 mL of urine to the tube and replace cap. Urine Chemistry: Some assays require a 24-hour collection that may contain boric acid, hydrochloric acid, or sodium carbonate as a preservative. Some analyses require a urine specimen without any additive. Refer to the specific test in this Directory of Services for specific test details. Instruct the patient to discard the first urine voided upon arising in the morning and thereafter collect all urine specimens in a paper cup and transfer to the 24-hour container, including the first morning voiding of the following day. A normal intake of fluid is recommended. Measure the 24-hour volume and record it on the container and the test request form. Keep the specimen refrigerated until picked up by the laboratory. Urine Chemistry tests that do not require a 24-hour collection container and can be submitted in a sterile cup; please keep refrigerated. Frozen Specimens Certain tests must be submitted frozen because of the viability of the analyte being tested. Keep all frozen specimens separate from the routine tests and submit a separate test request form. As soon as possible, separate the serum or plasma and transfer to a plastic transfer tube. Place the specimen in the office freezer and keep until it is solid. Notify the Transportation Department as soon as possible that you have a frozen specimen for pick up. PLEASE STORE YOUR SPECIMEN IN THE FREEZER UNTIL PICK UP, UNLESS SPECIFICALLY INSTRUCTED TO DO OTHERWISE. 14 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories S P E C I M E N P R E P A R A T I O N DIRECTORY OF SERVICES 2014 CYTOLOGY DIRECTIONS Aspiration Biopsy by Fine Needle (FNA) 1. Solid masses: Do direct smears and spray with cytology spray fixative immediately. 2. Fluids: Add directly to fixative supplied in special container. Method for Obtaining an Optimum Fine Needle Aspiration Specimen: A high percentage of smears are difficult, and sometimes impossible to accurately diagnose. This difficulty is primarily due to poorly preserved cellular material or a lack of adequate cellular material. Poorly preserved material is usually due to a delay in fixing the smears or spraying them too closely with the fixative and freezing the material. A lack of adequate cells is generally the result of a hypocellular cystic fluid spread too thinly over the slide. Direct Smears 1. Write patient’s name with lead pencil on frosted end of clean slide. 2. Spread material evenly over slide. 3.Fix immediately with cytology spray fixative from a distance of 10 to 12 inches until liquid droplets form. 4. Allow slide to dry before sending it out in designated slide holder. Fluids (Collected or Aspirated) 1. Write patient’s name on container. 2.All fluids, including bronchial washings, pleural, and peritoneal (ascitic) fluids, have to be placed in a container with an equal volume of 50% ethyl alcohol. 3. Send fluid immediately in securely closed containers. NOTE: A sputum specimen will be considered unsatisfactory for diagnosis if no pigmented macrophages (dust cells) are present. Gastrointestinal Tract Washings 1. Collect fasting specimen and transfer to a labeled container. 2. Rapidly inject 300 mL of normal saline. 3. Aspirate as much as possible of the injected saline and transfer to another labeled container. 4. If possible, repeat steps “2” and “3” with patient in different positions. 5. Specimens may be pooled or collected separately in containers of 95% ethyl alcohol. 6. Send immediately to lab. NOTE: A Gastrointestinal Tract Washing specimen will be considered unsatisfactory if it is not representative of the anatomic site or the slides are broken beyond repair. Urine for Cytology 1. Specimen can be randomly collected. 2. Female patients should be instructed to wash their genitalia with soap and water prior to collection. 3. Have the patient void into a paper cup and transfer to a container with 50% ethyl alcohol. 4. Send immediately to the laboratory in a securely closed container. 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories 15 S P E C I M E N P R E P A R A T I O N DIRECTORY OF SERVICES 2014 NOTE: INCLUDE PATIENT AGE AND PERTINENT CLINICAL DATA ON THE REQUEST FORM. If there are any questions about specimen collection, or if you need to order the container of fixative, call our Customer Service Department at (800) 627-1479. PATHOLOGY, ANATOMIC (BIOPSIES AND SURGICAL SPECIMENS) General Instructions 1.Use Surgical Pathology requisition form for all biopsies and surgical specimens. Relevant clinical information should be written down in the spaces provided. 2. Write patient’s name on specimen container. 3.Place all tissues immediately in 10% buffered formalin at 10 times the volume of the specimen. Specimen containers with 10% formalin are provided by the laboratory. 4.Send immediately to the laboratory in a securely closed container. For additional information, please contact Customer Service. NOTE: CPT Codes shown with tests are to be used as guidelines only and may be subject to change. Their accuracy is neither expressed nor implied in this compendium. Please consult the AMA CPT Code Book for further information. 16 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories S P E C I M E N H A N D L I N G A N D R E J E C T I O N DIRECTORY OF SERVICES 2014 SPECIMEN QUALITY AND REJECTION Hemolysis Some analytes may be reported erroneously if the serum is not promptly removed from the clot, or if the Barrier Gel Tube is not centrifuged after the clot has formed. Major discrepancies are low Glucose, high Potassium and LDH. Hemolyzed hematological specimens are unsuitable for testing. Inadequate Draw or Quantity Not Sufficient (QNS) Most tests that require anticoagulated specimens require that a full tube of blood be obtained. This is because there is a defined quantity of anticoagulant in each tube and the ratio of anticoagulant to the blood volume has to be exact to ensure quality results. Particularly important are Light Blue Top Tubes used for coagulation tests. For Prothrombin Times, Activated Partial Thromboplastin Times, and Fibrinogen determinations, blood must fill the tube to the fill line. For CBCs, a “short draw” Lavender Top Tube will result in red cell crenation, reduced MCV and Hematocrit, and possible changes in leukocyte morphology, platelets, and total leukocyte counts. QNS may also be seen when an inadequate volume of serum or plasma is submitted for the number of tests requested. Clotted Specimens All hematological testing utilizes anticoagulated blood. For blood counts, a Lavender Top Tube containing the anticoagulant EDTA is required. All specimens should be collected and the tube filled to the limit of the vacuum. Clotted samples, either macroscopic or microscopic in nature, cannot be processed for CBC testing, as such results will produce false leukopenia, low red cell counts, and aberrant red cell indices. As the equipment used to test blood counts incorporates a clot detector, it is occasionally possible that specimens that appear macroscopically normal will have small microscopic clots that are detected and that will produce incorrect results. Similarly, small clots found in Blue Top Tubes (for coagulation tests) will result in falsely-prolonged PT and PTT test results. Old Specimens Blood specimens older than 24 hours cannot be adequately tested for some analytes. Particularly sensitive are most Hematology tests, including coagulation procedures. Poor Cell Preservation Blood cells, particularly leukocytes, become fragile and can be distorted morphologically if the specimen is older than 24 hours. In such situations, a reliable differential white cell count cannot be carried out. Test Not Performed (TNP) TNP may be reported for one or more of the tests requested. This “result” is entered when a test cannot be performed on the submitted specimen (e.g. wrong tube, duplicate order, no longer stable, etc). 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories 17 C O N N E C T I V I T Y S O L U T I O N S DIRECTORY OF SERVICES 2014 CONNECTIVITY SOLUTIONS CareEvolve We offer many options for results reporting to physicians that include courier delivery of hard copies, report printers, structured HL7 results interface to EMRs, HL7 data to a repository via secure transfer, and our web-based electronic order and reporting system, CareEvolve. CareEvolve offers Computerized Provider Order Entry (CPOE) and secure access to lab results via the Internet. Order Entry A real-time bridge with the PMS eliminates duplicate entry of patient information. Frequently ordered tests and panels can be combined into a single group to streamline ordering. User-defined “favorite” tests appear “above the line”. Tests are automatically presented on the screen based on the provider’s ordering history. 18 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories DIRECTORY OF SERVICES 2014 Standing Orders are easily managed in CareEvolve Results Review If providers prefer to review results on paper, reports can be printed automatically upon sample completion or at pre-scheduled intervals. Alert ranges may be customized for each provider to indicate results that need review or require action. 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories 19 DIRECTORY OF SERVICES 2014 CareEvolve is browser independent and the touch-optimized software is easy to use on smart phones and tablets, as well as desktops. CareEvolve provides a Global Results Search function with the capability to screen results and to perform patient and practice-wide analytics. 20 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories DIRECTORY OF SERVICES 2014 The system also includes customized cumulative reporting, which allows the provider to select the tests to trend over a designated time period. The graphed reports are automatically generated and give the provider both historic and current test results at a glance, eliminating the need to search through past to see howfrom currentclinical results compare. GenPath —results one source, testing to bone marrow evaluation CareEvolve Online Clinical Trended Report Name Smith, Phil 3.5 DOB 08/10/1952 Age 58 PID 12345 SS# 555-55-5555 Sex Male 3.50 3.0 Gamma Glob. (SPEP) Ref Range: 0.70 - 1.90 g/dL Time Period: All 2.5 2.0 2.50 1.90 1.60 1.5 1.43 1.58 1.37 1.60 1.80 1.25 1.0 0.5 0.0 02/2013 11/2013 08/2012 02/2012 08/2011 [1] [2] [3] [4] [5] 02/2011 [6] 08/2010 [7] 02/2010 [8] 08/2009 [9] 02/2009 [10] Morphological Review and Final Diagnosis A Complete Pathology Solution STORMPATH is GenPath’s web-enabled digital pathology service that provides pathologists with a comprehensive service to interpret the technical component of esoteric testing. Through STORMPATH, pathologists can order new tests, analyze results and create patient reports efficiently. Our STORMPATH test menu includes: •F ISH: Interpret clear probe signals for hematological malignancies and solid tumors • Flow Cytometry: Interpret a complete library of cell surface markers • Breast IHC Markers: Quantify key markers such as ER, PgR, HER2, Ki-67 and p53 • UroVysion: Utilize FISH for bladder cancer assessment • Digital Slide Imaging: Digitally view more than 220 antibodies clearly • Surgical Biopsies: Provide custom reports for GI, GU, Derm and Prostate • Cytology: Create custom reports for cytological specimens in women’s health 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories 487 Edward H Ross Drive · Elmwood Park, NJ 07407 ·1 800 627 1479 tel · 1 201 791 8760 fax · www.genpathdiagnostics.com 21 DIRECTORY OF SERVICES 2014 TEST ADDITION AFTER SUBMISSION Our Customer Service department can arrange for additional testing if the specimen is stable and the volume is adequate after your requested tests have been completed. We are required by Federal mandates to ask for written or electronic authorization for every test we perform. You will receive a request for written confirmation for verbal requests via hard copy reporting or by fax. The physician or authorized employee must sign and return this written confirmation. GENPATH ACCESSION NUMBER FAX CHANGE IN TESTING AUTHORIZATION ACCOUNT NAME: PATIENT NAME: DATE: FAX: ACCOUNT # FAXED BY: Submitted Specimens: Cytology Slide(s) Urine(s) Other: Dear: The following additional tests have been ADDED to those requested for the patient: Reason(s): Person spoke with: Title: The following tests have been DELETED from those requested for the patient: PLEASE SIGN BELOW: I authorized the above changes in testing __________________________________ Physician designated authorized signature __________________ TITLE ________________ DATE 481 Edward H Ross Drive I Elmwood Park NJ 07407 I tel 800 633 4522 I fax 201 791 3046 / 201 345 7152 I www.genpathdiagnostics.com 22 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories A M A D I S E A S E - S P E C I F I C PA N E L S A P P R O V E D F O R G O V E R N M E N T DIRECTORY OF SERVICES 2014 AMA DISEASE-SPECIFIC PANELS APPROVED FOR GOVERNMENT HEALTH PLANS CodeProfile 3283-9 Acute Hepatitis Panel Hepatitis A Antibody (HA Ab), IgM (86709) Hepatitis B Core Antibody (HBcAb), IgM Antibody (86705) Hepatitis B Surface Antigen (HBsAg) (87340) Hepatitis C Antibody (86803) 2555-1 Basic Metabolic Panel Calcium, Total (82310) Carbon Dioxide (Bicarbonate) (82374) Chloride (82565) Creatinine (82565) Glucose, Serum (82947) Ionized Calcium (82330) Potassium (84132) Sodium (84295) Blood Urea Nitrogen (BUN) (84520) 3427-2 Comprehensive Metabolic Panel Albumin (82040) Bilirubin, Total (82247) Calcium, Total (82310) Carbon Dioxide (Bicarbonate) (82374) Chloride (82565) Creatinine (82565) Glucose (82947) Phosphatase, Alkaline (84075) Potassium, Serum (84132) 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories 23 A M A D I S E A S E - S P E C I F I C PA N E L S A P P R O V E D F O R G O V E R N M E N T DIRECTORY OF SERVICES 2014 24 Protein, Total (84155) Sodium, Serum (84295) Transferase, Alanine Amino (ALT) (SGPT) (84460) Transferase, Aspartate Amino (AST) (SGOT) (84450) Blood Urea Nitrogen (BUN) (84520) 0002-6 Electrolytes Panel Carbon Dioxide (Bicarbonate) (82374) Chloride, Blood (82435) Potassium, Serum (84132) Sodium, Serum (84295) 3422-3 Hepatic Function Panel/Liver Panel Albumin (82040) Bilirubin, Total (82247) Bilirubin, Direct (82248) Alkaline Phosphatase (84075) Protein, Total (84155) Transferase, Alanine Amino (ALT) (SGPT) (84460) Transferase, Aspartate Amino (AST) (SGOT) (8440) 3284-7 Renal Function Panel Albumin (82040) Calcium, Total (82310) Carbon Dioxide (Bicarbonate) (82374) Chloride (82435) Creatinine (82565) Glucose (82947) Phosphorus, Inorganic (Phosphate) (84100) Potassium, Serum (84132) Sodium, Serum (84295) Blood Urea Nitrogen (BUN) (84520) 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories BRANDED REPORTS DIRECTORY OF SERVICES 2014 BRANDED REPORTS GenPath reports provide easy-to-read information, which may include: • Previous test results • Abnormalities highlighted in yellow • Easy to find final diagnosis • Detail clinical abnormalities summary ® Final Report D OD CO TC OT RO SMITH, SUSAN ONCOLOGY CENTER DR. EXAMPLE 123 MAIN STREET ELMWOOD PARK, NJ 07407 ACCT #: ABCDE 60 P: 555-555-5555 FX F: 555-555-5555 R P A P T A I T E I N E T N T SAMPLE, REPORT DOB: 9/10/1966 Age: 44Y Sex: M SAMPLE, REPORT Surgical #: XXXXXXXX DOB: Age: Sex: Patient ID: 55555555 Surgical #: Address: 123 MAIN STREET Patient ID: ANYTOWN, NJ 01451 Address: Phone: (999) 999-9999 S A S M A P M L P LE E Final Report Specimen ID: 111111111 Date of Report: 04/14/2013 10:40 AM Specimen ID: 555555555 Date Collected: 04/06/2013 3:00 PM Date of Report: 04/14/2013 10:40 AM Date Received: 04/07/2013 3 Date Collected: Source: Bone marrow (R. post/sup I.C.) 3 Date Received: Clinical Information: CML restaging, on Source: Tasigna Clinical Information: INTEGRATED HEMATOPATHOLOGY SUMMARY REPORT FINAL DIAGNOSIS Pathologist’s diagnosis comparing current biopsy vs. previous (1) Histologic and cytogenetic remission, history of CML. (2) Residual molecular disease, with slightly less than a 2 log decrease in BCR/ABL from the initial marrow. COMPARATIVE REVIEW OF CURRENT AND PRIOR RESULTS RESULTS Method Interpretation Result Normal Abnormal Current Specimen ID: 111111111 301552308 Collection Date: 4/6/13 4/6/11 Morphology Result Normal Abnormal 301281225 Prior Specimen ID: 222222222 Collection Date: 4/9/12 4/19/10 X Markedly hypercellular marrow with marked myeloid hyperplasia consistent with chronic myelogenous leukemia, chronic phase (see comment). No morphologic evidence of accelerated phase or acute leukemia. Absent storage iron. X BCR/ABL rearrangement is detected. X 46,XX,t(9;22)(q11.2;q34)[20] X BCR/ABL1 IHC FISH Cytogenetics Molecular X BCR/ABL1 Detected BCR/ABL1 of b2a2 Type: Not Detected BCR/ABL1 of b3a2 Type: 4.79% BCR/ABL1 of e1a2 Type: Not Detected Detected BCR/ABL1 of b2a2 Type: Not Detected BCR/ABL1 of b3a2 Type: 227.093% BCR/ABL1 of e1a2 Type: Not Detected James Weisberger, M.D. 3 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories 25 B R A N D E D R E P O R T S DIRECTORY OF SERVICES 2014 BRANDED REPORTS (CONT.) D O C T O R SMITH, JOHN GRACE, WILLIAM ONCOLOGY CENTER WILLIAM GRACE, M.D. 123 MAIN STREET 1384 BROADWAY ELMWOOD NJ 07407 New York,PARK, NY 10018 ACCT ABCDE 60 Acct #:#: (C0062-9) 51 P: (212) 675-6826 P:555-555-5555 F: 555-555-5555 P A T I E N T FINAL REPORT SAMPLE, REPORT SIDRAN, MIRIAM DOB: 10/21/1920 Age: 92Y Sex: F DOB:05/25/1920 Age:92 Y Sex:F Surgical XXXXXXXX ID: #:0000000815 Patient ID: 55555555 Address:210 W 19TH STREET Address: 123 MAIN STREET NEW YORK, NY 10011 P: (212) 627-6475 ANYTOWN, NJ 01451 Phone: (999) 999-9999 S A M P L E Specimen ID: 111111111 Specimen ID: 103246842 Date of Report:02/06/2013 Date Of Report: 02/06/2013 Date Date Collected:02/05/2013 Collected: 02/05/2013 Date Time Received:07/15/2013 Collected: 10:32 Time Date Collected: 10:32 02/05/2013 Received: Received: 21:56 Date Time Received: 02/05/2013 Time Received: 21:56 CLINICAL REPORT Albumin AST FERRITIN e-GFR GGTP CEA 3.4 LO 34 HI 364 HI 52 LO 174 HI 5.9 HI Calcium 8.4 LO CA 27.29 112.9 HI NON FASTING Previous test result CHEMISTRY Test Result Total Protein Albumin Globulin A/G Ratio Glucose Sodium Potassium Chloride CO2 BUN Creatinine e-GFR e-GFR, African American BUN/Creat Ratio Calcium Uric Acid 6.5 Iron Bilirubin, Total LD Alk Phos Reference Units g/dL g/dL g/dL 6.9 5.9-8.4 3.5-5.2 1.7-3.7 1.1-2.9 70-99 133-145 3.3-5.3 96-108 22-29 8-23 0.60-1.30 >60 >60 10.0-28.0 8.6-10.2 2.5-7.9 95 0.4 201 140 3.1 1.1 79 134 4.7 98 23 18 0.99 63 18.2 Abnormal mg/dL mg/dL 30-160 0.1-1.0 135-214 40-156 ug/dL mg/dL U/L U/L 107 0.6 264 HI 170 HI 01/22/2013 01/22/2013 01/22/2013 01/22/2013 <32 2.7-4.5 <33 6-42 1.6-2.6 U/L mg/dL U/L U/L mg/dL 37 HI 3.3 32 238 HI 2.2 01/22/2013 01/22/2013 01/22/2013 01/22/2013 01/22/2013 Reference Units <200 <150 mg/dL mg/dL Abnormal Reference Units 364 HI 10-291 26-192 ng/mL U/L 3.4 LO 52 LO 8.4 LO 34 HI 3.2 22 174 HI 1.9 CARDIOVASCULAR/LIPIDS Test Result Cholesterol Triglycerides 143 66 Test Result MISCELLANEOUS Date 01/22/2013 01/22/2013 01/22/2013 01/22/2013 01/22/2013 01/22/2013 01/22/2013 01/22/2013 01/22/2013 01/22/2013 01/22/2013 01/22/2013 01/22/2013 01/22/2013 01/22/2013 01/22/2013 NOTE: New reference ranges for Alkaline Phosphatase effective 11/26/12. AST Phosphorus ALT GGTP MAGNESIUM Previous Result 6.9 4.0 2.9 1.4 71 136 4.4 100 20 LO 20 1.06 48 LO 58 LO 18.9 9.2 8.0 HI NOTE: New reference ranges for Uric Acid effective 11/26/12. FERRITIN CK Abnormal 41 BioReference Laboratories, Inc. 481 Edward H. Ross Dr | Elmwood Park, NJ 07407 | (800) 627-1479 mg/dL mmol/L mmol/L mmol/L mmol/L mg/dL mg/dL mL/min mL/min James Weisberger, M.D. Laboratory Director Previous Result 172 74 Previous Result 418 HI 39 Date 01/22/2013 01/22/2013 Date 01/07/2013 01/22/2013 Clinical Page 1 of 2 Printed 11/14/13 02:02 PM GenPath is a business unit of BioReference Laboratories, Inc. 26 Abnormalities are summarized at the top of the report 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories Abnormal testing results clearly identified B I L L I N G P O L I C Y A N D I N S U R A N C E S DIRECTORY OF SERVICES 2014 BILLING POLICIES AND INSURANCE COVERAGE GenPath, a division of BioReference Laboratories, Inc., will be billing as BioReference Laboratories. Direct Billing To Patient GenPath can bill your patients directly for our services. The patient’s full name and street address (including apartment number, city, state, and zip code) must be clearly printed in the space provided on the requisition. A complete address at the time the test is ordered is essential. Each requisition will result in a separate bill to the patient. Payment of patient bills is due upon receipt and, if not paid, will be followed by subsequent reminders and normal collection activity. 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When ordering any of the tests above, outside of their corresponding utilization guidelines and without additional documentation, please have the patient sign the Advanced Beneficiary Notice (ABN), so they may be billed directly for the test. 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories 27 B I L L I N G P O L I C Y A N D I N S U R A N C E S DIRECTORY OF SERVICES 2014 GENERAL BILLING INFORMATION At your discretion, GenPath billing as BioReference will (1) bill your office directly for services rendered to your patients (in those States that allow direct billing), (2) bill your patient, and (3) bill any of the third-party insurance carriers that BioReference is able to bill directly, provided your patient is an enrollee of one of these third-party carriers and you provide us with the necessary information. 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Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories B I L L I N G P O L I C Y A N D I N S U R A N C E S DIRECTORY OF SERVICES 2014 LICENSES AND REGULATORY INFORMATION BioReference Laboratories in Elmwood Park currently holds licenses for testing in the following states, as well as a CLIA Certificate issued by the Centers for Medicare and Medicaid Services (CMS). CLIA Certificate College of American Pathologists #31D0652945 #LAP12372-01 CMS Medicare #301910 Cytology/Pathology #CY305343 New York State Permit #PFI3130 New Jersey State License #0000283 Maryland State Permit Pennsylvania State Permit Florida State License Rhode Island State License California State License #COS800242 DEA Registration #RBO215726 West Virginia State License Vermont State Certificate #482 #022757A #800004934 #LC000305 #RL17 HIV, Urine Drugs 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories 41 DIRECTORY OF SERVICES 2014 HOW TO USE THE TEST DIRECTORY This directory describes the diagnostic testing and ancillary services that can assist you and your staff in providing the best possible medical care to your patients. The major section of this directory is the alphabetical test listing by test name. This section describes in detail, the specimen requirements and clinical utility of each test. In addition to the alphabetical listing, tests are listed by test code. Our Test Format Test Code Test Name Alphabetical Test Listing 5027-8 Burkitt Lymphoma: MYC/IGH,t(8;14) by FISH MYC/IGH by FISH AlternateName: Name:MYC/IGH MYC/IGH t(8;14) Burkitt Lymphoma, c-MYC Alternate t(8;14) forfor Burkitt Lymphoma 5027-8 Methodology: FISH Methodology: FISH 2mL Green-Bone Marrow Preferred Specimen: CPT Code: 88368(2) Preferred Specimen: 2 mL Bone Marrow, Tissue in RPMI CPT Code: 88368 (2) Alternate Specimen: 5mL Green-Whole Blood Alternate Specimen: 5 mL Peripheral Blood - Green Top Storage Instruction: Room Temp Specimen Comment: Please include specimen collection date on requisition. Turnaround time: 3-5 days Storage Instruction: Refrigerate Clinical Indication Turnaround time: :3Useful days for assessment of Burkitt Lymphoma. Clinical Indication: Useful for assessment of Burkitt Lymphoma. Ref Range: See Report 0009-1 Lipid Panel Legend for Test Directory Alternate Name: Lipid Screen FISH: Fluorescence In Situ Hybridization Preferred Specimen: 2 mL Serum - Spun Barrier Tube IHC: Immunohistochemistry Alternate Specimen: Chain Reaction PCR: Polymerase Methodology: See components CPTCode: 80061 Collection Instruction: Storage Instruction: Refrigerate Turnaround time: 2 - 3 days Components: #0058, Cholesterol, Total #0059, HDL Chol., Direct #0155, Triglycerides Clinical Indication : A lipid panel is a blood test that measures lipids—fats and fatty substances used as a source of energy by your body. Lipids include cholesterol, triglycerides, high-density lipoprotein (HDL), and low-density lipoprotein (LDL). This panel measures: Total cholesterol level, Triglyceride level, HDL cholesterol level. This is the “good” cholesterol, LDL cholesterol level. This is the “bad” cholesterol. 0327-7 Human Chorionic Gonadotropin (hCG), β- Subunit, Quantitative, Serum Alternate Name: Pregnancy, Quant./Beta Sub-Unit Preferred Specimen: 2 mL Serum - Spun Barrier Methodology: See components CPTCode: 84702 Tube & - PLAIN Red Top Alternate Specimen: Collection Instruction: avoid hemolysis Storage Instruction: Refrigerate Turnaround time: 5 - 7 days 42 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com Components: GenPath is a business unit of BioReference Laboratories Clinical Indication : The level of hCG in the blood is often used as part of a screening for birth defects in a maternal serum triple or quadruple screening test. Generally done between 15 and 20 weeks, these tests check the levels of three or four substances in a pregnant woman’s blood. The triple screen checks alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG), and a type DIRECTORY OF SERVICES 2014 L A B O R AT O RY T E S T S IN ALPHABETICAL ORDER 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories 43 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 -5/5q- by FISH- TC Only A869-0 Alternate Name: -5/5Q- BY FISH-TC ONLY Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367-TC (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: MDS with isolated 5q- is a discrete subset of MDS with a favorable prognosis. Unlike the majority of MDS, most patients with 5q- syndrome are elderly woman, with a 2:1 female predominance. Lenalidomide (an immunmodulatory drug) is FDA approved for 5qMDS. Commonly ordered through the MDS FISH panel (TC Only), P960-8. -7/7q- by FISH- TC Only A868-2 Alternate Name: -7/7Q- BY FISH-TC ONLY Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367-TC (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: 7q- is a common cytogenetic abnormality found in MDS. Entire or partial deletions of chromosome 7 generally confer an intermediate prognosis when found in isolation. Genetic alterations of 7 is a poor prognosis when found in conjunction with other cytogenetic abnormalities of clinical significance. Commonly ordered through the MDS FISH panel (TC Only), P960-8. 11q22.3 by FISH- TC Only A879-9 Alternate Name: 11Q22.3 BY FISH-TC ONLY Methodology: FISH Preferred Specimen: 5 mL Peripheral Blood - Green Top CPT Code: 88367 (1) Alternate Specimen: 2 mL Bone Marrow - Green Top Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: FISH for 11q23 provides useful prognosic and therapeutic information. CLL patients with 11q23 deletion have rapid disease progression and shorter treatment free survival. This deletion in the ATM gene, a tumor supressor gene, occurrs in 10-20% of CLL cases. Commonly ordered through the CLL FISH panel (TC Only), P962-4. 13q14 by FISH- TC Only A872-4 Alternate Name: 13Q14 BY FISH-TC ONLY Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367-TC (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: FISH for 13q14.3 (D13S319) provides useful prognostic information in the management of CLL patients. Deletions involving 13q14 are detectable by FISH in approximately 50% of persons with CLL. As the sole aberration, del(13q) is associated with a more favorable clinical outcome. However, recent studies have shown that certain CLL patients with a larger size deletion in 13q14 correlate strongly with a concomitant RB1 deletion. Patients with an RB1 deletion or those have a 13q14.3 deletion in > or equal to 70% of nuceli have in fact a shorter time to treatment. Commonly ordered through the Multiple Myeloma FISH panel (TC Only), P961-6. A1 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 13q14.3 by FISH- TC Only A878-1 Alternate Name: 13Q14.3 BY FISH-TC ONLY Methodology: FISH Preferred Specimen: 5 mL Peripheral Blood - Green Top CPT Code: 88367 (1) Alternate Specimen: 2 mL Bone Marrow - Green Top Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: FISH for 13q14.3 (D13S319) provides useful prognostic information in the management of CLL patients. Deletions involving 13q14 are detectable by FISH in approximately 50% of persons with CLL. As the sole aberration, del(13q) is associated with a more favorable clinical outcome. However, recent studies have shown that certain CLL patients with a larger size deletion in 13q14 correlate strongly with a concomitant RB1 deletion. Patients with an RB1 deletion or those have a 13q14.3 deletion in > or equal to 70% of nuceli have in fact a shorter time to treatment. Commonly ordered through the CLL FISH panel (TC Only), P962-4. 17p13 by FISH- TC Only A874-0 Alternate Name: 17P13 BY FISH-TC ONLY Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367-TC (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: 17p or p53 is commonly referred to as a universally poor prognostic factor in hematological malignancies. A unifying molecular genetic abnormality in these cases appears to be a deletion or inactivation of one copy of the TP53 gene, with subsquent inactivation of the second allele. Commonly ordered through the CLL FISH panel (TC Only), P962-4. 1p/19q by FISH A311-3 Alternate Name: 1P/19Q,D(1;19)DELETION BY FISH Methodology: FISH Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88368 (2) Alternate Specimen: Unstained Slide Specimen Comment: Please include specimen collection date and surgical number on block and on requisition. Provide fixation time on requisition as well Turn Around Time: 13 days Clinical Indication: As an aid in diagnosing oligodendroglioma tumors and predicting the response of an oligodendroglioma to therapy. 1q21 by FISH- TC Only A876-5 Alternate Name: 1Q21 BY FISH-TC ONLY Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367-TC (2) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: FISH is used to detect the amplification of 1q21, a poor prognostic marker for Plasma Cell Myeloma. Commonly ordered through the Multiple Myeloma FISH panel (TC Only), P961-6. 20q12 by FISH- TC Only A871-6 Alternate Name: 20Q12 BY FISH-TC ONLY Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367-TC (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: Deletions in 20q12 is a favorable prognostic marker for myelodysplastic syndrome (MDS). It also can be helpful to aid in the diagnosis of MDS in the presence of negative morphological findings. Commonly ordered through the MDS FISH panel (TC Only), P960-8. 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A2 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Acute Hepatitis Panel for Medicare 3283-9 Alternate Name: ACUTE HEPATITIS PANEL Preferred Specimen: SST Tube CPT Code: 80074 (1) Alternate Specimen: Red Top,Aliquot Tube-Serum,Microtainer - Pediatric SST,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 2 days Components: HEPATITIS A Ab,IgM, HEPATITIS B CORE Ab,IgM, HBsAg, HEPATITIS C Ab. Clinical Indication: Comprehensive profile for detecting markers for HAV or HBV infections; can be used for all stages of infection Acute Leukemia & Myeloid Disorders Analysis 5515-2 Alternate Name: FLOW ACUTE LEUKEMIA PNL Methodology: Flow Cytometry Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88184 (1), 88185 (27), 88189 (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Tissue in RPMI,Peripheral Blood - Lavender Top,Bone Marrow - Lavender Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Flow Cytometry is highly sensitive and specific in diagnosing non-Hodgkin lymphoma and acute leukemias and in identifying granulocytic, monocytic, erythroid, and megakaryocytic differentiation. Flow allows examination and characterization of normal myeloid, monocytic, and immature hematopoietic precursors and their specific, synchronized patterns of antigen expression. Ref Range: See Report Acute Leukemia & Myeloid Disorders Analysis- TC Only 5516-0 Alternate Name: LEUK/LYM/MYE/MYELO;TECH COM Methodology: Flow Cytometry Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88184 (1), 88185 (27) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Tissue in RPMI,Peripheral Blood - Lavender Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Flow Cytometry is highly sensitive and specific in diagnosing non-Hodgkin lymphoma and acute leukemias and in identifying granulocytic, monocytic, erythroid, and megakaryocytic differentiation. Flow allows examination and characterization of normal myeloid, monocytic, and immature hematopoietic precursors and their specific, synchronized patterns of antigen expression. Ref Range: See Report Acute Leukemia/MDS IHC Panel 5116-9 Alternate Name: Acute Leukemia/MDS IHC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1), G4062 (10) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: The Acute Leukemia/MDS IHC panel is used to assess lineage and blast cell count in the context of AML, ALL and/or MDS diagnosis. The components of this panel include: CD3, CD10, CD20, CD34, CD56, CD61, CD79a, CD117, Glycophorin-A, HLA-DR, MPO and TdT. Ref Range: See Report Adenocarcinoma vs. Mesothelioma IHC Panel 5181-3 Alternate Name: ADENOCARCINOMA V.MESOTHEL. Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1), G0462 (8) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: The IHC panel is useful in the differential diagnosis between adenocarcinoma and mesothelioma. The components of this panel include: BerEP4, Calretinin, CD68, CEAm, Desmin, GLUT-1, MOC31, Napsin A and TTF-1. Ref Range: See Report A3 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 AE1/AE3- TC Only Alternate Name: GP/AE1/AE3 (STAIN ONLY) Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days 5108-6 CPT Code: G0461-TC (1) ALK by FISH A703-1 Alternate Name: ALK-2P23 BY FISH Methodology: FISH Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88368 (2) Alternate Specimen: Unstained Slide Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Room Temp Turn Around Time: 3-5 days Clinical Indication: The detection of EML4-ALK fusion is used as a screening assay to determine a lung cancer patient's eligibility for crizotinib, a tyrosine kinase inhibitor. Ref Range: See Report ALK by FISH (FDA) A241-2 Alternate Name: EML4/ALK Methodology: FISH Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88368 (2) Alternate Specimen: Unstained Slide Specimen Comment: Storage Instruction: Room Temp Turn Around Time: 3-5 days Clinical Indication: FISH for EML4-ALK is used to detect the presence of a fusion gene that can be targeted with an FDA approved tyrosine kinase inhibitor, crizotinib. All NSCLC adenocarcinoma patients can be tested for EML4-ALK but clinicopathologic features favor patients with little to no smoking history and those that are younger. CAP guidelines recommend EGFR and ALK testing in advanced stage adenocarcinoma regardless of sex, smoking history, and other clinical factors. Expert concensus opinion written in the CAP guidelines recommend EGFR and ALK testing for all stages of adenocarcinoma. ALK by FISH can also be used to confirm a diagnosis of Anaplastic Large Cell Lymphoma (ALCL) because it covers ALK1 status. Ref Range: See Report ALK by FISH- TC Only B236-1 Alternate Name: ALK BY FISH (TC) Methodology: FISH Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88367 (2) Alternate Specimen: Unstained Slide Specimen Comment: Please include specimen collection date on requisition. Please write surgical number on block and on requisition. Provide fixation time on requisition as well Storage Instruction: Room Temp Turn Around Time: 3-5 days Clinical Indication: FISH for EML4-ALK is used to detect the presence of a fusion gene that can be targeted with an FDA approved tyrosine kinase inhibitor, crizotinib. All NSCLC adenocarcinoma patients can be tested for EML4-ALK but clinicopathologic features favor patients with little to no smoking history and those that are younger. CAP guidelines recommend EGFR and ALK testing in advanced stage adenocarcinoma regardless of sex, smoking history, and other clinical factors. Expert concensus opinion written in the CAP guidelines recommend EGFR and ALK testing for all stages of adenocarcinoma. ALK by FISH can also be used to confirm a diagnosis of Anaplastic Large Cell Lymphoma (ALCL) because it covers ALK1 status. 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A4 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 ALK by IHC - TC Only B603-2 Alternate Name: ALK (EML4/ALK by IHC TC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88342-TC (1) Alternate Specimen: Unstained Slide Specimen Comment: *Provide Source* Will also accept 2 unstained slides form FFPE tissue. Storage Instruction: Room Temp Turn Around Time: 1 days Clinical Indication: The detection of EML4-ALK protein overexpression is used as a screening assay to determine a lung cancer patient's eligibility for crizotinib, a tyrosine kinase inhibitor. ALL Prognosis Panel by FISH P260-3 Alternate Name: ALL PROGNOSIS PNL/FISH Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88368 (3) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition, Time Sensitive Storage Instruction: Refrigerate Turn Around Time: 3 days Components: BCR/ABL, MLL, 11q23 Clinical Indication: Used to detect common genetic aberrations in B-cell Lymphoblastic Leukemia/Lymphoma. Alpha Fetoprotein, Tumor Marker (AFP) 0025-7 Alternate Name: AFP, TUMOR MARKER Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 82105 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Alpha Fetoprotein marker is used in the management of hepatocellular carcinoma and germ cell tumors. Ref Range: <8.4 ng/mL,<8.1 ng/mL AML - CEBPA Mutational Analysis 8860-9 Alternate Name: CEBPA MUT. ANALYSIS Methodology: PCR Preferred Specimen: 2 mL Bone Marrow - Lavender Top CPT Code: 81403 (1) Alternate Specimen: 5 mL Peripheral Blood - Lavender Top,Peripheral Blood - Green Top,Bone Marrow - Green Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 3-4 days Clinical Indication: In the context of normal cytogenetics AML patients with biallelic CEBPA mutations have a favorable prognosis. Risk adopted treatment strategies can be adopted for such patients. Ref Range: See Report AML - M2 (AML/ETO) (RUNX1/RUNX1T1) by FISH 5024-5 Alternate Name: AML1/ETO,t(8;21), FISH Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88368 (2) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Please include specimen collection date on requisition, Time Sensitive Storage Instruction: Refrigerate Turn Around Time: 3 days Clinical Indication: FISH for t(8;21) is both diagnostic and prognostic for AML. AML patients with translocations between chromosomes 8 and 21 are a specific WHO subset defined as AML/ETO. Approximately 5-12% of all AML patients share a t(8;21) mutation which is regarded as a favorable prognostic marker. Ref Range: See Report A5 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 AML - M2 (AML/ETO) (RUNX1/RUNX1T1) by RT-PCR 5034-4 Alternate Name: AML1/ETO,t(8;21),PCR Methodology: PCR Preferred Specimen: 2 mL Bone Marrow - Lavender Top CPT Code: 81401 (1) Alternate Specimen: 5 mL Peripheral Blood - Lavender Top,Peripheral Blood - Green Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Turn Around Time: 4 days Clinical Indication: Serial monitoring of patients for minimal residual disease and determine treatment efficacy. Ref Range: See Report AML - M3 (PML/RARA) by FISH 5260-5 Alternate Name: PML/RARA,t(15;17),FISH Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367 (2) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Please include specimen collection date on requisition, Time Sensitive Storage Instruction: Refrigerate Turn Around Time: 3 days Clinical Indication: FISH for the detection of translocation between the PML and RARA genes is used for diagnostic and therapeutic management. The WHO defines patients with t(15;17)(q22;q12) as a subset of AML that is associated with favorable prognosis. Ref Range: See Report AML - M3 (PML/RARA) by RT-PCR 5261-3 Alternate Name: PML/RARA,(15;17)PCR Methodology: PCR Preferred Specimen: 2 mL Bone Marrow - Lavender Top CPT Code: 81315 (1) Alternate Specimen: 5 mL Peripheral Blood - Lavender Top,Peripheral Blood - Green Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required Storage Instruction: Refrigerate Turn Around Time: 2 days Clinical Indication: RT-PCR for PML/RARA has a similar utility as the FISH assay. However, RT-PCR has a lower limit of detection and is useful for serial monitoring of patients for MRD. Ref Range: See Report AML - M4 & M5 by FISH 5427-0 Alternate Name: MLL, 11q23 Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88368 (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Please include specimen collection date on requisition, Time Sensitive Storage Instruction: Refrigerate Turn Around Time: 3 days Clinical Indication: AML patients with 11q23 rearrangement define a specific WHO subcategory of AML. These patients typically have monocytic features and comprise 5-6% of all AML patients. AML with 11q23 is more common in children. It is typically a poor prognostic factor. Ref Range: See Report AML - M4Eo inv(16) by FISH 5025-2 Alternate Name: CBFB/MYH11 (inv16), FISH Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88368 (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Please include specimen collection date on requisition, Time Sensitive Storage Instruction: Refrigerate Turn Around Time: 3 days Clinical Indication: FISH to detect the inversion of chromosome 16 is diagnostic and prognostic for patients with Acute Myelomonocytic Leukemia. AML patients with inversion 16 have a more favorable prognosis than those with normal karyotype. Ref Range: See Report 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A6 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 AML - M4Eo inv(16) by PCR 5035-1 Alternate Name: CBFB/MYH11 (INV16), PCR Methodology: PCR Preferred Specimen: 2 mL Bone Marrow - Lavender Top CPT Code: 81401 (1) Alternate Specimen: 5 mL Peripheral Blood - Lavender Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 4 days Clinical Indication: RT-PCR testing for chromosme 16 inversion has similar utility to that of the FISH assay but can be additively used for MRD and monitoring of treatment effectiveness. Ref Range: See Report AML Diagnostic Panel by FISH P261-1 Alternate Name: AML DIAGNOSTIC BY FISH Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88368 (8) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition, Time Sensitive Storage Instruction: Refrigerate Turn Around Time: 3 days Components: BCR/ABL, MLL, 11q23, AML1/ETO,t(8;21), FISH, PML/RARA,t(15;17),FISH, CBFB/MYH11 (inv16), FISH Clinical Indication: Comprehensive FISH panel that interrogates all common chromosome abnormalities for accurate WHO subset classification. AML Prognostic Panel: FLT3 & NPM1 5988-1 Alternate Name: AML PROGNOSIS PANEL Methodology: PCR Preferred Specimen: 2 mL Bone Marrow - Lavender Top CPT Code: 81245 (1), 81310 (1) Alternate Specimen: 5 mL Peripheral Blood - Lavender Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 4-7 days Components: FLT-3 MUTATION, NPM1 MUTATION ANALYSIS Clinical Indication: Panel used as predictors for risk stratification for patients with AML. AML-M3(PML/RARA) by FISH- TC Only A881-5 Alternate Name: AML-M3(PML/RARA)BY FISH Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367-TC (2) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition, Time Sensitive Storage Instruction: Refrigerate Turn Around Time: 3 days Clinical Indication: Diagnostic assay for the detection of translocation between PML and RARA genes. Patients positive for t(15;17) represent a WHO defined subset whose prognosis is favorable and are managed accordingly. AML: NPM1 Mutation Analysis Alternate Name: NPM1 MUTATION ANALYSIS Methodology: PCR Preferred Specimen: 2 mL Bone Marrow - Lavender Top CPT Code: 81310 (1) Alternate Specimen: 5 mL Peripheral Blood - Lavender Top,Peripheral Blood - Green Top,Bone Marrow - Green Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 3-4 days Clinical Indication: Prognostic indicator for patients with AML. It is recommended that FLT3 be run before ordering NPM1. Ref Range: See Report A7 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. 5269-6 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Anti-Thyroglobulin Antibody (ATA) 0041-4 Alternate Name: ANTI-THYROGLOBULIN Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 86800 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Detect and confirm autoimmune thyroiditis, Hashimoto's thyroiditis. Ref Range: <40 IU/mL Antinuclear Antibody (ANA) 0038-0 Alternate Name: ANA SCREEN Methodology: Indirect Fluorescence Assay Preferred Specimen: 1 mL SST Tube CPT Code: 86038 (1) Alternate Specimen: Microtainer - Pediatric SST,Aliquot Tube-Serum,Red Top,Microtainer - Pediatric Red Specimen Comment: Positive result will reflex to ANA TITER-3185 at additional charge Storage Instruction: Refrigerate Turn Around Time: 2 days Clinical Indication: Used to screen for certain autoimmune disorders, such as systemic lupus erythematosus (SLE) and others. Ref Range: Neg=<1:80 Antistreptolysin O (ASO) Titer 0042-2 Alternate Name: ASO Methodology: Immunoturbidometric Preferred Specimen: 1 mL SST Tube CPT Code: 86060 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 2 days Clinical Indication: Used to assess whether a person has had a recent streptococcal infection. Ref Range: <150 IU/mL,<200 IU/mL,See Below IU/mL Automated UroVysion By FISH 5030-2 Alternate Name: AUTOMATED UROVYSION by FISH Methodology: FISH Preferred Specimen: 50 mL ThinPrep Cytolyte Solution CPT Code: 88121 (1) Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: For help detecting and monitoring bladder cancer (urothelial or transitional cell carcinoma). Ref Range: See Report B-Cell, IGH by FISH 5032-8 Alternate Name: IGH, FISH Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88368 (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Tissue in RPMI,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Please include specimen collection date on requisition Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: Useful for assessment of B-cell clonality, as seen in B-cell lymphoma. Ref Range: See Report 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A8 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 B-Cell, IGH by PCR 5278-7 Alternate Name: ICH, PCR Methodology: PCR Preferred Specimen: 2 mL Bone Marrow - Lavender Top CPT Code: 81261 (1) Alternate Specimen: 5 mL Peripheral Blood - Lavender Top,Tissue in RPMI,Formalin-fixed, Paraffin-embedded Tissue,Peripheral Blood Green Top,Shavings Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 3-4 days Clinical Indication: Useful for assessment of B-cell clonality, as seen in B-cell lymphoma. Ref Range: See Report BCL1, BCL2, BCL6 (FISH Panel) 5273-8 Alternate Name: NON-HODGKINS LYMPHOMA PNL,FISH Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88368 (5) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Tissue in RPMI,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Components: BCL1,t(11;14),FISH, BCL-2,t(14;18),FISH, LG.CELL LYMPHOMA(BCL-6)FISH Clinical Indication: Useful for assessment of Non-Hodgkin Lymphoma. BCL1/IGH (CCND1/IGH) by FISH 5026-0 Alternate Name: BCL1,t(11;14),FISH Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88368 (2) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Tissue in RPMI,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: Useful for assessment of Mantle cell lymphoma and as a prognostic indicator for plasma cell myeloma. Ref Range: See Report BCL1/IGH (CCND1/IGH) by FISH-TC Only A873-2 Alternate Name: T(11;14)+11 BY FISH-TC Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367-TC (2) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: Prognostic for patients with Plasma Cell Myeloma. Commonly ordered through the Multiple Myeloma FISH panel (TC Only), P961-6. BCL2/IGH by FISH 5270-4 Alternate Name: BCL-2,t(14;18),FISH Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88368 (2) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Tissue in RPMI,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Please include specimen collection date on requisition Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: Useful for assessment of follicle center lymphomas. Ref Range: See Report A9 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 BCL2/IGH by PCR Alternate Name: GP/BCL-2,T(14;18),PCR Methodology: PCR Preferred Specimen: 2 Bone Marrow - Lavender Top Alternate Specimen: 5 mL Peripheral Blood - Lavender Top,Tissue in RPMI Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 3-4 days Clinical Indication: Useful for assessment of follicle center lymphomas. Ref Range: See Report 5271-2 CPT Code: 81402 (1) BCL2/IGH: t(14;18) by FISH- TC Only Alternate Name: BCL2 BY FISH-TC Methodology: FISH Preferred Specimen: 2 mL Formalin-fixed, Paraffin-embedded Tissue Alternate Specimen: Tissue in RPMI,Unstained Slide Specimen Comment: Please include specimen collection date on requisition Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: Useful for assessment of follicle center lymphomas. B350-0 CPT Code: 88367-TC (2) BCL6 by FISH 5028-6 Alternate Name: LG.CELL LYMPHOMA(BCL-6)FISH Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88368 (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Tissue in RPMI,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: Useful for assessment of Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). BCL6 3q27 is found in up to 35% of DLBCL and 6-14% of FL. Ref Range: See Report BCL6: 3q27 by FISH- TC Only B348-4 Alternate Name: BCL6 BY FISH-TC Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367 (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Tissue in RPMI Specimen Comment: Please include specimen collection date on requisition Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: Useful for assessment of Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). BCL6 3q27 is found in up to 35% of DLBCL and 6-14% of FL. BCR/ABL by FISH-TC Only A880-7 Alternate Name: BCR/ABL BY FISH-TC ONLY Methodology: FISH Preferred Specimen: 5 mL Peripheral Blood - Green Top CPT Code: 88367-TC (2) Alternate Specimen: 2 mL Bone Marrow - Green Top Specimen Comment: Please include specimen collection date on requisition, Time Sensitive Storage Instruction: Refrigerate Turn Around Time: 3 days Clinical Indication: FISH for BCR/ABL is used to diagnose CML, is a prognostic indicator for B-cell Lymphoblastic Leukemia/Lymphoma, and is used to monitor patients response to tyrosine kinase inhibitor therapy. Before initiating treating with a TKI it may be helpful to order ABL Kinase analysis in order to better inform on which TKI to utilize. 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A10 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 BCR/ABL Quantification by RT-PCR 5858-6 Alternate Name: QNT.,RT-PCR,BCR/ABL1 Methodology: PCR Preferred Specimen: 5 mL Peripheral Blood - Lavender Top CPT Code: 81206 (1), 81207 (1) Alternate Specimen: 2 mL Bone Marrow - Lavender Top,Green top,Microtainer - Pediatric Green Top,Peripheral Blood - Green Top,Bone Marrow - Green Top Specimen Comment: If submitting bone marrow, 2 ml is required. Storage Instruction: Refrigerate Turn Around Time: 2 days Clinical Indication: The detection of BCR/ABL by RT-PCR has similar utility as the FISH assay. However, RT-PCR is generally used for MRD and response to tyrosine kinase inhibitor therapy due to its greater sensitivity, approximately .01%. Ref Range: See Report BCR/ABL: t(9;22) by FISH 5265-4 Alternate Name: BCR/ABL Methodology: FISH Preferred Specimen: 5 mL Peripheral Blood - Green Top CPT Code: 88367 (2) Alternate Specimen: 2 mL Bone Marrow - Green Top,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Place bone marrow (2 ml req.) into tube, label with patient's name. Send in bone marrow kit. Storage Instruction: Refrigerate Turn Around Time: 3 days Clinical Indication: FISH for BCR/ABL is used to diagnose CML, is a prognostic indicator for B-cell Lymphoblastic Leukemia/Lymphoma, and is used to monitor patient response to tyrosine kinase inhibitor therapy. Before initiating treating with a TKI it may be helpful to order ABL Kinase analysis in order to better inform on which TKI to utilize. Ref Range: See Report Beta-2-Microglobulin, Serum 0262-6 Alternate Name: BETA-2 MICROGLOBULIN Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 82232 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Beta-2 microglobulin has prognostic utility and can be used as a tumor marker for plasma cell myeloma, lymphoma, and CLL. Ref Range: <2.16 mg/L Beta-2-Microglobulin, Urine, Random 1754-1 Alternate Name: BETA-2-MICRO., URINE Methodology: Chemiluminescence Preferred Specimen: 4 mL Urine Cup CPT Code: 82232 (1) Alternate Specimen: Cup-other (source required),Urine Urinalysis Tube - Yellow,Urine tube without preservative Specimen Comment: use NaOH to adjust PH to 6-8 (ship cold). Turn Around Time: 2 days Clinical Indication: Evaluate the severity and prognosis of multiple myeloma, chronic lymphocytic leukemia, or non-Hodgkin's lymphoma; detect kidney damage and distinguish between glomerular and tubular kidney disorders. Ref Range: <0.300 mg/L Bone Marrow Morphology 5199-5 Alternate Name: BONE MARROW ANALYSIS Methodology: Morphology Preferred Specimen: Bone Marrow - Clot in Formalin,Unstained Slide,Bone Marrow CPT Code: 88313 (4), 88311 (1), 85097 (1), 88305 (2) Core in Formalin Specimen Comment: Submit core/clot in formalin. Send smear in slide holder. Turn Around Time: 1-2 days Clinical Indication: Bone marrow analysis is used to detect the presence of neoplasia in the bone marrow and as the primary means for the classification of most hematological malignancies. A11 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Bone Marrow Morphology - Clot Only 5202-7 Alternate Name: BONE MARROW ANALYSIS (CLOT) Methodology: Morphology Preferred Specimen: Bone Marrow - Clot in Formalin CPT Code: 88305 (1), 88313 (2) Specimen Comment: Turn Around Time: 1-2 days Clinical Indication: Bone marrow analysis is used to detect the presence of neoplasia in the bone marrow and as the primary means for the classification of most hematological malignancies. Bone Marrow Morphology - Core Only 5200-1 Alternate Name: BONE MARROW ANALYSIS (CORE) Methodology: Morphology Preferred Specimen: Bone Marrow Core in Formalin CPT Code: 88305 (1), 88313 (2), 88311 (1) Specimen Comment: Turn Around Time: 1-2 days Clinical Indication: Bone marrow analysis is used to detect the presence of neoplasia in the bone marrow and as the primary means for the classification of most hematological malignancies. Bone Marrow Morphology - Smears 5211-8 Alternate Name: BONE MARROW ANALYSIS, SMEARS ONL Methodology: Morphology Preferred Specimen: Unstained Slide CPT Code: 88313 (1), 85097 (1) Alternate Specimen: Stained Slides Specimen Comment: Turn Around Time: 1-2 days Clinical Indication: Bone marrow analysis is used to detect the presence of neoplasia in the bone marrow and as the primary means for the classification of most hematological malignancies. Ref Range: See Report Bone Marrow Slide Consult 5207-6 Alternate Name: BONE MARROW SLIDE CONSULT. Methodology: Morphology Preferred Specimen: Stained Slides CPT Code: 88321 (1) Specimen Comment: Turn Around Time: 1-2 days Clinical Indication: Bone marrow analysis is used to detect the presence of neoplasia in the bone marrow and as the primary means for the classification of most hematological malignancies. Ref Range: See Report Bone Marrow Smear Interpretation Alternate Name: GP/BM SMEAR INTERPRETATION Methodology: Morphology Preferred Specimen: Stained Slides Specimen Comment: Submit bone marrow smear. Turn Around Time: 2 days Ref Range: See Report 5285-2 CPT Code: 85097 (1) 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A12 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 BRAF V600E 5893-3 Alternate Name: BRAF V600E MUTATION Methodology: PCR Preferred Specimen: 5 mL Peripheral Blood - Lavender Top CPT Code: 81210 (1), 88381 (1) Alternate Specimen: Peripheral Blood - Green Top,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide,Shavings Specimen Comment: Turn Around Time: 2-3 days Clinical Indication: BRAF V600E/K mutational analysis is useful in the context of melanoma, colon cancer, thyroid cancer, and hairy cell leukemia. Melanoma patients, metastatic or unresectable, with V600E (and in some cases V600K) are eligible for treatment with tyrosine kinase inhibitor therapy. In colon cancer BRAF may be used as a screening assay for MSI high positive or unstable patients suspected of Lynch Syndrome. BRAF V600E can aid the diagnosis of papillary thyroid cancer (PTC) from cytology samples. It is specifically helpful in cases of undeterminate cytology. Numerous studies have shown BRAF to be associated with aggressive clinicopathologic features of PTC. It can also be used to confirm a diagnosis of hairy cell leukemia. Ref Range: See Report BRAF V600E (FDA) A566-2 Alternate Name: BRAF V600 Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81210 (1), 88381 (1) Alternate Specimen: Unstained Slide,Shavings Specimen Comment: Source and pathology report is required. Turn Around Time: 3 days Clinical Indication: BRAF V600E mutation by COBAS is an FDA approved companion diagnostic for the indication of vemurafenib in metastatic or unresectable melanoma. Ref Range: See Report Breast Carcinoma, Marrow, IHC Micromets Alternate Name: BRCA,MARROW,IHC MICROMETS Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Assess for bone marrow micrometastasis in breast cancer. Ref Range: See Report 5118-5 CPT Code: G0461 (1) Breast Carcinoma, rule out Microinvasion 5176-3 Alternate Name: CARCINOMA PANEL Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1), G0462 (3) Alternate Specimen: Unstained Slide Specimen Comment: The components of this panel include: Calponin, CD10, p63 and SMM-HWC. Turn Around Time: 1 days Clinical Indication: Used to rule out microinvasion. Ref Range: See Report Breast Carcinoma, rule out Microinvasion- TC Only A952-4 Alternate Name: BREAST MICROINVASION-TC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461-TC (1), G0462-TC (3) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Used to rule out microinvasion. The components of this panel include: Calponin, CD10, p63 and SMM-HWC. A13 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Breast Carcinoma/Lymph Nodes/MM Metastasis Alternate Name: BREAST CA/LYMPH NODES/MM Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Assess for nodal metastatic carcinoma. Ref Range: See Report 5170-6 CPT Code: G0461 (1) C-Reactive Protein (hs-CRP), High Sensitivity 3320-9 Alternate Name: hsCRP Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 86141 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: See Below mg/L CA 125, Serum 0536-3 Alternate Name: CA-125 Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 86304 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 2 days Clinical Indication: Tumor marker used to monitor treatment of ovarian cancer and to detect possible recurrence. Ref Range: <36.0 U/mL,<30.3 U/mL CA 15-3, Serum 2130-3 Alternate Name: CA 15-3 Methodology: Chemiluminescence Preferred Specimen: 1 mL Red Top CPT Code: 86300 (1) Alternate Specimen: SST Tube,Microtainer - Pediatric SST,Microtainer - Pediatric Red,Aliquot Tube-Serum Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 2 days Clinical Indication: Used to monitor the response to treatment of invasive breast cancer and detect recurrence of the disease. Ref Range: <or=32.4 U/mL CA 19-9, Serum 0535-5 Alternate Name: CA 19-9 Methodology: Chemiluminescence Preferred Specimen: 2 mL Red Top CPT Code: 86301 (1) Alternate Specimen: SST Tube,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 2 days Clinical Indication: Used for the prognosis of pancreatic carcinoma. Ref Range: <or=35.0 U/mL 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A14 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 CA 27.29, Serum 0823-5 Alternate Name: CA 27.29 Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 86300 (1) Alternate Specimen: Microtainer - Pediatric SST,Aliquot Tube-Serum,Red Top,Microtainer - Pediatric Red Specimen Comment: RED-TOP ACCEPTABLE BUT SERUM MUST BE SEPARATED. DO NOT ADD AFTER 24 HRS. Storage Instruction: Refrigerate Turn Around Time: 2 days Clinical Indication: For detection of breast cancer recurrence. Ref Range: <or=38.6 U/mL Calcium, Urine, 24 Hours 0359-0 Alternate Name: CALCIUM,URINE 24 HR Methodology: Colorimetry Preferred Specimen: 10 mL Urine Container - 24hr CPT Code: 82340 (1), 81050 (1) Alternate Specimen: Urine Cup 24 hour,Urine Tube 24 hour Specimen Comment: No preservative required. Refrigerate. Storage Instruction: Refrigerate Turn Around Time: 2 days Clinical Indication: For diagnosis and monitoring of a wide range of disorders including disorders of protein, vitamin D, and diseases of bone, kidney, parathyroid gland, or gastrointestinal tract Carcinoembryonic Antigen (CEA) 0055-4 Alternate Name: CEA Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 82378 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Intended for the in vitro quantitative determination of carcinoembryonic antigen in human serum and plasma Ref Range: See Below ng/mL CBC w/Diff, Platelet Ct. 0053-9 Alternate Name: CBC WITH DIFF Preferred Specimen: Lavender top- EDTA CPT Code: 85025 (1) Alternate Specimen: Microtainer - Pediatric Lavender Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Components: HCT, WBC, RBC, HGB, PLATELET COUNT Clinical Indication: Broad assessment of white blood cell count with differential, red cell counts and indices, and platelet count. Chlamydia trachomatis (CT), Urine, Probetec Alternate Name: C.TRACH.,AMPLI. Methodology: PCR Preferred Specimen: Urine Tube BD CPT Code: 87491 (1) Alternate Specimen: Urine Cup,Urine tube without preservative Specimen Comment: COLLECT FIRST MORNING URINE (NO PRESERVATIVES) Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: Negative A15 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. 2665-8 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Chromosome Analysis 5250-6 Alternate Name: CHROMOSOME ANALYSIS Methodology: Cytogenetics Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88237 (1), 88262 (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition. Peripheral blood accepted only for leukemias. Storage Instruction: Refrigerate Turn Around Time: 5-7 days Clinical Indication: Cytogenetic analysis used to determine chromosomal abnormalities important in diagnosis of hematologic malignancies, disease monitoring, and response to certain treatments. Ref Range: See Report Circulating Tumor Cells (CTC) 6237-2 Alternate Name: CELLSEARCH CIRCULATING TUMOR CEL Methodology: Indirect Fluorescence Assay Preferred Specimen: 7.5 mL Whole Blood-Cell Save Preservative Tube CPT Code: 86152 (1), 86153 (1) Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 3 days Clinical Indication: Measures number circulating tumor cells and can assess for residual disease. Ref Range: See Report Citrate, 24Hr. Urine 0021-6 Alternate Name: CITRATE,24hr.URN. Preferred Specimen: 4 mL Urine Container - 24hr CPT Code: 82507 (1) Alternate Specimen: Urine Cup 24 hour,Urine Tube 24 hour Specimen Comment: Record total volume, collection time interval, and pH on transport tube. Storage Instruction: Refrigerate Turn Around Time: 3 days Ref Range: See Report mg/24hrs CK-903 for Prostate Cancer Alternate Name: GP/CK-903, IHC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Ref Range: See Report 5434-6 CPT Code: G0461 (1) CK-903- TC Only Alternate Name: CK903 PROSTATE CANCER (TECH) Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Ref Range: See Report 5404-9 CPT Code: G0461-TC (1) 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A16 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 CLL FISH Panel 5280-3 Alternate Name: P53/D13S319/ATM/+12 Methodology: FISH Preferred Specimen: 5 mL Peripheral Blood - Green Top CPT Code: 88368 (4) Alternate Specimen: 2 mL Bone Marrow - Green Top,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Please include specimen collection date on requisition Storage Instruction: Refrigerate Turn Around Time: 3-5 days Components: P53 by FISH Clinical Indication: The CLL FISH panel is a comprehensive prognostic panel for treatment stratification. CLL FISH Panel- TC Only P962-4 Alternate Name: CLL FISH PANEL- TC ONLY Methodology: FISH Preferred Specimen: 5 mL Peripheral Blood - Green Top CPT Code: 88367-TC (4) Alternate Specimen: 2 mL Bone Marrow - Green Top Specimen Comment: Please include specimen collection date on requisition Storage Instruction: Refrigerate Turn Around Time: 3-5 days Components: TRISOMY 12 BY FISH-TC, 13Q14.3 BY FISH-TC ONLY, 17P13 BY FISH-TC ONLY, 11Q22.3 BY FISH-TC ONLY Clinical Indication: The CLL FISH panel is a comprehensive prognostic panel to allow for enhanced disease management. CML: ABL Kinase Mutation Analysis 6290-1 Alternate Name: ABL KINASE MUT.ANAL(NJ ETC.) Methodology: PCR Preferred Specimen: 5 mL Peripheral Blood - Lavender Top CPT Code: 81401 (1) Alternate Specimen: 2 mL Bone Marrow - Lavender Top,Peripheral Blood - Green Top,Bone Marrow - Green Top Specimen Comment: Place bone marrow into tube, label with patient's name. Send in bone marrow kit. Storage Instruction: Refrigerate Turn Around Time: 3-4 days Clinical Indication: Measures unfavorable response to Imatinib mesylate (Gleevec) in patients with CML. Assesses for ABL mutations, including T315I, which may confer resistance to TKIs. Ref Range: See Report Colon DNA Mismatch Repair Reflex Alternate Name: COLON DNA MISMCH REP Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue Alternate Specimen: Unstained Slide Specimen Comment: Please provide a copy of the pathology report. Turn Around Time: 3 days Components: MICRO SATELLITE INSTABILITY Clinical Indication: Useful in the assessment of Lynch Syndrome. P264-5 CPT Code: 81301 (1) Colon Reflex Dx B365-8 Alternate Name: COLON REFLEX DX PANEL Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81301 (1), 81275 (1), 88381 (1) Alternate Specimen: Unstained Slide Specimen Comment: Storage Instruction: Room Temp Turn Around Time: 6-8 days Clinical Indication: Testing algorithm designed to provide a comprehensive analysis of common colon cancer genetic abnormalities. KRAS and MSI testing are performed to detect abnormalities that affect treatment decision; tyrosine kinase inhibitor therapy and chemotherapy, respectively. The latter half of the algorithm is intended to rule out Lynch Syndrome. KRAS and MSI with a reflex to BRAF and MLH1 to screen for Lynch Syndrome. Ref Range: See Report A17 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Complement C3, Serum 0532-2 Alternate Name: COMPLEMENT C3 Methodology: Immunoturbidometric Preferred Specimen: 1 mL SST Tube CPT Code: 86160 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Used in the diagnosis of C3 deficiency and investigation of a patient with a low to absent total complement (CH[50]) level. Ref Range: 90-180 mg/dL Complement C4, Serum 0533-0 Alternate Name: COMPLEMENT C4 Methodology: Immunoturbidometric Preferred Specimen: 1 mL SST Tube CPT Code: 86160 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Used in the diagnosis of C4 deficiency and investigation of a patient with a low to absent total complement (CH[50]) level. Ref Range: 10-40 mg/dL Comprehensive Metabolic Panel (CMP) 3427-2 Alternate Name: COMP. METABOLIC (CMP) Preferred Specimen: 1 mL SST Tube CPT Code: 80053 (1) Alternate Specimen: Aliquot Tube-Serum,Microtainer - Pediatric SST Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Components: Total Protein, Albumin, Calcium, Creatinine, Bilirubin, Total, Alk Phos, AST, Sodium, Potassium, Chloride, CO2, BUN, Glucose, ALT Clinical Indication: For determining status of kidneys, liver, electrolytes, acid/base balance and blood sugar and protein levels. Ref Range: See Report Comprehensive Slide Consult Alternate Name: COMPREHENSIVE SLIDE CONSULT Methodology: Morphology Preferred Specimen: Stained Slides Specimen Comment: Turn Around Time: 1-2 days Clinical Indication: Slide consultation 5256-3 CPT Code: 88325 (1) Comprehensive Urine Pathology Alternate Name: COMP.URN.,PATHOLOGY Methodology: FISH Preferred Specimen: 50 mL Voided Urine - Urocyte Collection Kit Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: To aid in the diagnosis of bladder cancer. Ref Range: See Report 5324-9 CPT Code: 88121 (1), 88112 (1) 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A18 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Comprehensive Urine Pathology- TC Only 5253-0 Alternate Name: COMPREHENSIVE URN PATHOLOGY TC Methodology: FISH Preferred Specimen: 50 mL Voided Urine - Urocyte Collection Kit,ThinPrep Cytolyte CPT Code: 88121-TC (1), 88112-TC (1) Solution Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: To aid in the diagnosis of bladder cancer. Coombs Test, Direct 0064-6 Alternate Name: DIRECT COOMBS Preferred Specimen: Pink Tube-EDTA CPT Code: 86880 (1) Alternate Specimen: Microtainer - Pediatric Lavender,Lavender top- EDTA,Yellow top- ACD Specimen Comment: Submit an extra lavender top tube if ordering CBC. Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: To detect antibodies bound to red cells in autoimmune or allo-immune hemolytic anemia. Ref Range: Negative Cortisol, Serum, Random 0900-1 Alternate Name: CORTISOL, RANDOM Methodology: Chemiluminescence Preferred Specimen: 1 mL Red Top CPT Code: 82533 (1) Alternate Specimen: Microtainer - Pediatric SST,Aliquot Tube-Serum,SST Tube,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 2 days Ref Range: 2.5-25.0 ug/dL,3.1-22.4 ug/dL Creatinine Clearance, Urine, 24 Hours Alternate Name: CREATININE, CLEAR,(24 Preferred Specimen: 2 mL SST Tube,Urine Container - 24hr Specimen Comment: Provide total volume on requisition and on container Storage Instruction: Refrigerate Turn Around Time: 2 days Components: Creatinine Ref Range: 0072-9 CPT Code: 82575 (1) Culture, Blood Alternate Name: CULTURE, BLOOD Methodology: Bacterial Culture Preferred Specimen: Blood Culture Bottles-Aerobic/Anaerobic CPT Code: 87040 (1) Alternate Specimen: Yellow top- SPS Specimen Comment: Observe Aerobic/Anerobic Collection instructions Storage Instruction: Room Temp Turn Around Time: 6 days Clinical Indication: Isolate and identify potentially pathogenic organisms causing bacteremia. Ref Range: A19 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. 0341-8 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Culture, Urine 0080-2 Alternate Name: URINE CULTURE Methodology: Bacterial Culture Preferred Specimen: 10 mL Urine Container-Boricult CPT Code: 87086 (1) Alternate Specimen: Urine Tube - Grey Top,Urine Cup,Urine tube without preservative Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 4 days Ref Range: No Growth Culture, Wound, Aerobic Only 0082-8 Alternate Name: WOUND CULTURE PANEL Methodology: Bacterial Culture Preferred Specimen: Swab-E CPT Code: 87205 (1), 87077 (1), 87075 (1) Alternate Specimen: Swab-Bacterial Culture,Cup-other (source required),Swab-Amies with Charcoal-Black Specimen Comment: Turn Around Time: 5 days Components: GRAM STAIN Ref Range: No Growth CYP2C19 Pharmacogenomic (Plavix) 5847-9 Alternate Name: CYP2C19 Methodology: PCR Preferred Specimen: 5 mL Lavender top- EDTA CPT Code: 81225 (1) Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 7 days Clinical Indication: Measures response to the usual standard dose of clopidogrel and determines if patient requires alternate forms of antiplatelet therapy. Ref Range: See Report CYP2D6 (NY Only): Tamoxifen Resistance Alternate Name: P450 2D6 GENOTYPE Methodology: PCR Preferred Specimen: 5 mL Peripheral Blood - Lavender Top Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 6-8 days Clinical Indication: Assessment for efficacy of tamoxifen. Ref Range: See Report 5296-9 CPT Code: 81225 CYP2D6: Tamoxifen Resistance (non-NY only) Alternate Name: CYP2D6 Methodology: PCR Preferred Specimen: 5 mL Peripheral Blood - Lavender Top Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 7 days Clinical Indication: Assessment for efficacy of tamoxifen. Ref Range: See Report 5287-8 CPT Code: 81226 (1) 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A20 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Cytomegalovirus (CMV) Antibody, IgG 0400-2 Alternate Name: CMV Ab.(IgG) Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 86644 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 2 days Clinical Indication: Aid in diagnosis of CMV infection. Ref Range: Neg=<0.9 Cytomegalovirus (CMV) Antibody, IgM 0461-4 Alternate Name: CMV Ab.(IgM) Methodology: Enzyme Linked Immunoabsorbance Preferred Specimen: 1 mL SST Tube CPT Code: 86645 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 2 days Clinical Indication: Aid in diagnosis of CMV infection. Ref Range: <0.91 DNA Ploidy for Molar Pregnancy Alternate Name: DNA PLOIDY FOR MOLAR PREG. Methodology: Flow Cytometry Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Assess for Partial Hydatidiform Mole. Ref Range: See Report 5555-8 CPT Code: 88182 (1) DNA Ploidy/S-Phase by Flow Cytometry Alternate Name: DNA CELL CYCLE (PLOIDY)/FLOW Methodology: Flow Cytometry Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Prognostic indicator in breast cancer patients. Ref Range: See Report 5575-6 CPT Code: 88182 (1) DPD 5-FU Genotype 6285-1 Alternate Name: DPD-5 FU GENOTYPE Methodology: PCR Preferred Specimen: 5 mL Peripheral Blood - Lavender Top CPT Code: 81400 (1) Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 7 days Clinical Indication: Partial or complete deficiency of DPD activity has been associated with an increased risk for severe adverse reactions when treated with pyrimidine-based chemotherapeutic agents, such as 5-fluorouracil (5-FU). The test can also be used to confirm the clinical diagnosis of dihydropyrimidine dehydrogenase (DPD) deficiency in affected patients and for the detection of the IVS14+1G>A mutation in asymptomatic carriers. Ref Range: See Report A21 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 EBV Capsid Ab, IgG 0234-5 Alternate Name: EBV CAPSID Ag.Ab/IgG Methodology: Multiplex Flow Immunoassay Preferred Specimen: 1 mL SST Tube CPT Code: 86665 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: <0.9 AI EBV Capsid Ab, IgM 0580-1 Alternate Name: EBV CAPSID Ag.Ab/IgM Methodology: Multiplex Flow Immunoassay Preferred Specimen: 1 mL SST Tube CPT Code: 86665 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: <0.9 AI EBV, Early Antigen Ab 0582-7 Alternate Name: EBV EARLY Ag.Ab Methodology: Multiplex Flow Immunoassay Preferred Specimen: 1 mL SST Tube CPT Code: 86663 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: <0.9 AI EBV, Nuclear Antigen Ab, IgG 0583-5 Alternate Name: EBNA Ab/IgG Methodology: Multiplex Flow Immunoassay Preferred Specimen: 1 mL SST Tube CPT Code: 86664 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: <0.9 AI EGFR by PCR 5295-1 Alternate Name: EGFR BY PCR Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81235 (1), 88381 (1) Alternate Specimen: Tissue,Eppendorf tube,Unstained Slide,Shavings Specimen Comment: Turn Around Time: 3-4 days Clinical Indication: NCCN recommended test for assessment of the effectiveness of erlotinib and other TKI therapies. Ref Range: See Report 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A22 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 EGFR by PCR if neg. reflex to ALK A675-1 Alternate Name: EGFR PCR RFX NEG>EML4 Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81235 (1), 88381 (1) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 3-5 days Clinical Indication: This test is used for patients with non-small-cell lung cancer, primarily adenocarcinoma histology, to determine appropriateness of tyrosine kinase inhibitor therapy. CAP guidelines recommend EGFR and ALK testing in advanced stage adenocarcinoma regardless of sex, smoking history, and other clinical factors. Expert concensus opinion written in the CAP guidelines recommend EGFR and ALK testing for all stages of adenocarcinoma. Ref Range: See Report Electrolytes, Serum Alternate Name: ELECTROLYTES Preferred Specimen: 2 mL SST Tube Alternate Specimen: Microtainer - Pediatric SST,Aliquot Tube-Serum Specimen Comment: Do not use Red-top tube. Storage Instruction: Refrigerate Turn Around Time: 1 days Components: Sodium, Potassium, Chloride, CO2 Ref Range: 0002-6 CPT Code: 80051 (1) Electrophoresis, Urine Protein (UPEP) 0404-4 Alternate Name: PROTEIN ELECT.,U Methodology: Electrophoresis Preferred Specimen: 1 mL Urine Cup CPT Code: 84166 (7), 84156 (1) Alternate Specimen: Urine tube without preservative Specimen Comment: Use code Q069 for 24 hr urine. Storage Instruction: Refrigerate Turn Around Time: 3 days Components: M SPIKE,UPEP, PROTEIN,URN.TIMED/RAND Clinical Indication: Detects urine albumin, urine alpha, urine beta, and urine gamma globulin fractions if present, including various patterns of proteinuria (glomerular, tubular, Bence Jones monoclonal light chains). EML4-ALK by IHC B565-3 Alternate Name: ALK (EML4/ALK) BY IHC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1) Alternate Specimen: Unstained Slide Specimen Comment: Storage Instruction: Room Temp Turn Around Time: 1 days Clinical Indication: The detection of EML4-ALK protein overexpression is used as a screening assay to determine a lung cancer patient's eligibility for crizotinib, a tyrosine kinase inhibitor. ER / PR - w/Interpretation 5198-7 Alternate Name: ER/PR RECEP.PROFILE Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361 (2) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: IHC analysis of hormone receptors ER and PR are used for treatment stratification and to subtype breast carcinomas. Hormone directed therapies such as selective estrogen receptor modulators (SERMS) are appropriately utilized in the context of ER results. Ref Range: See Report A23 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 ER / PR / DNA / Ki-67 - w/Interpretation 5160-7 Alternate Name: ER/PR/DNA/Ki-67 W/INTERP. Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361 (3), 88182 (1) Alternate Specimen: Unstained Slide Specimen Comment: DNA testing by FLOW cytometry. Turn Around Time: 1 days Clinical Indication: IHC analysis of hormone receptors ER and PR are used for treatment stratification and to subtype breast carcinomas. DNA and Ki-67 are are prognostic markers for disease progression. Ref Range: See Report ER / PR / Ki-67 / HER2- TC Only 5433-8 Alternate Name: BREAST PROF.V(er/pr) Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361-TC (4) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Hormone receptor (ER/PR) and HER2 status in breast carcinoma at diagnosis has been established as a clinically useful standard of care parameter to determine treatment options and prediction of patient response. Accurate IHC analysis is critical to setting the appropriate treatment strategy for patients with breast carcinoma. Ki-67 is a cell proliferation marker used in breast carcinoma for prognosis prediction. ER / PR / Ki-67/ HER2 - w/Interpretation 5163-1 Alternate Name: ER/PR/KI-67/HER2/IHC/INTER. Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361 (4) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Hormone receptor (ER/PR) and HER2 status in breast carcinoma at diagnosis has been established as a clinically useful standard of care parameter to determine treatment options and prediction of patient response. Accurate IHC analysis of ER/PR/HER2 is critical to setting the appropriate treatment strategy for patients with breast carcinoma. Ki-67 is a cell proliferation marker used in breast carcinoma for prognosis prediction. Ref Range: See Report ER / PR / Ki-67 / HER2 (Tech Only), plus DNA (Global) 5131-8 Alternate Name: ER/PR/KI67/HER-2+DNA,IHC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361-TC (4), 88182 (1) Alternate Specimen: Unstained Slide Specimen Comment: DNA testing by FLOW cytometry. Turn Around Time: 1 days Clinical Indication: Hormone receptor (ER/PR) and HER2 status in breast carcinoma at diagnosis has been established as a clinically useful standard of care parameter to determine treatment options and prediction of patient response. Accurate IHC analysis of ER/PR/HER2 is critical to setting the appropriate treatment strategy for patients with breast carcinoma. Ki-67 is a cell proliferation marker used in breast carcinoma for prognosis prediction. DNA ploidy measures the amount of DNA content and proliferative activity (cell cycle/S-phase fraction) in analyzed tumor cells as predictors of prognosis. Ref Range: See Report 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A24 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 ER / PR / DNA / Ki-67 / HER2 - w/Interpretation 5162-3 Alternate Name: ER/PR/DNA/KI-67/HER2, IHC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361 (4), 88182 (1) Alternate Specimen: Unstained Slide Specimen Comment: DNA testing by FLOW cytometry. Turn Around Time: 1 days Clinical Indication: Hormone receptor (ER/PR) and HER2 status in breast carcinoma at diagnosis has been established as a clinically useful standard of care parameter to determine treatment options and prediction of patient response. Accurate IHC analysis of ER/PR/HER2 is critical to setting the appropriate treatment strategy for patients with breast carcinoma. Ki-67 is a cell proliferation marker used in breast carcinoma for prognosis prediction. DNA ploidy measures the amount of DNA content and proliferative activity (cell cycle/S-phase fraction) in analyzed tumor cells as predictors of prognosis. Ref Range: See Report ER / PR / DNA / Ki-67 / HER2 - Reflex to HER2 by FISH 5408-0 Alternate Name: ER/PR/DNA/KI-67/HER2 W/RFLX Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361 (4), 88182 (1) Alternate Specimen: Unstained Slide Specimen Comment: DNA testing by FLOW cytometry. This comes in block from client with surgical number imprint. This comes in block from client with surgical number imprint. Turn Around Time: 3-5 days Clinical Indication: Comprehensive breast cancer profile that is useful for subtyping and treatment selection. Ref Range: See Report ER / PR / HER2 - w/Interpretation 5161-5 Alternate Name: ER/PR/HER2-NEU W/INTERP. Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361 (3) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Useful to determine appropriate treatment for breast cancer, hormonal therapy and targeted HER2 therapy. Ref Range: See Report ER / PR / HER2 - Reflex to HER2 by FISH 5406-4 Alternate Name: ER/PR/HER2-RFX BY FISH Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361 (3) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 3-5 days Clinical Indication: Useful to determine appropriate treatment for breast cancer, hormonal therapy and targeted HER2 therapy. Ref Range: See Report ER / PR / HER2 FISH- TC Only A277-6 Alternate Name: ER,PR,HER2 FISH TECH ONLY Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361-TC (2), 88367-TC (1) Alternate Specimen: Unstained Slide Specimen Comment: Please include specimen collection date on requisition. Turn Around Time: 3 days Clinical Indication: Useful to determine appropriate treatment for breast cancer, hormonal therapy and targeted HER2 therapy. A25 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 ER / PR / HER2- TC Only 5127-6 Alternate Name: ER/PR/HER2, IHC (TC ONLY) Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361-TC (3) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Useful to determine appropriate treatment for breast cancer, hormonal therapy and targeted HER2 therapy. ER / PR / Ki-67 / p53 / HER2 FISH- TC Only A278-4 Alternate Name: ER,PR,KI-67,P53,HER2 FISH, TC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361-TC (4), 88367-TC (1) Alternate Specimen: Unstained Slide Specimen Comment: Please include specimen collection date on requisition. Turn Around Time: 3 days Clinical Indication: Comprehensive breast cancer profile that is useful for subtyping and treatment selection. ER / PR / Ki-67 / HER2 - Reflex to HER2 by FISH 5407-2 Alternate Name: ER/PR/KI-67/HER2 W/REFLEX Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361 (4) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 3-5 days Clinical Indication: Useful to determine appropriate treatment for breast cancer, hormonal therapy and targeted HER2 therapy. Ki-67 is a cell proliferation marker used for prognosis in breast cancer. Ref Range: See Report ER / PR / Ki-67 / HER2 / p53, TC Only A951-6 Alternate Name: ER/PRKI-67/HER2/P53-TC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361-TC (5) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Hormone receptor (ER/PR) and HER2 status in breast carcinoma at diagnosis has been established as a clinically useful standard of care parameter to determine treatment options and prediction of patient response. Accurate IHC analysis is critical to setting the appropriate treatment strategy for patients with breast carcinoma. Ki-67 is a cell proliferation marker used in breast carcinoma for prognosis prediction. ER / PR / Ki-67- TC Only, plus DNA- Global 5129-2 Alternate Name: ER/PR/KI67+DNA, IHC (TC ONLY) Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361-TC (3), 88182 (1) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: IHC analysis of hormone receptors ER and PR are used to subtype breast carcinomas and for treatment selection. DNA and Ki-67 are prognostic markers for disease progression. 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A26 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 ER / PR / Ki67 / p53 / HER2 FISH -TC Only plus DNA- Global A276-8 Alternate Name: ER,PR,KI67,P53,HER2 FISH TC/DNA Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361-TC (4), 88367-TC (1), 88182 (1) Alternate Specimen: Unstained Slide Specimen Comment: Please include specimen collection date on requisition. DNA testing by FLOW cytometry. Turn Around Time: 3 days Clinical Indication: Comprehensive breast cancer profile that is useful for subtyping and treatment selection. Ref Range: See Report ER / PR- TC Only 5425-4 Alternate Name: ER/PR (TECH COMPONENT ONLY) Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361-TC (2) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: IHC analysis of hormone receptors ER and PR are used to subtype breast carcinomas. Hormone directed therapies such as selective estrogen receptor modulators (SERMS) are appropriately utilized in the context of ER results. Ref Range: See Report ERCC1 A300-6 Alternate Name: ERCC1 by PCR Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81479 (1) Alternate Specimen: Unstained Slide,Shavings Specimen Comment: Turn Around Time: 5-7 days Clinical Indication: ERCC1 mRNA expression is a prognosis marker and clinical biomarker for cisplatin-based chemotherapies in lung cancer. Ref Range: See Report Erythropoietin, Serum 0183-4 Alternate Name: ERYTHROPOIETIN Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 82668 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Low levels of EPO are associated with anemia of decreased cell production and Polycythemia vera. Elevated levels of EPO are associated with anemia of increased red cell destruction. Ref Range: 2.59-18.50 mIU/mL Estradiol, Serum 0516-5 Alternate Name: ESTRADIOL Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 82670 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: See Below pg/mL,<20-53 pg/mL,<5.00-20.00 pg/mL,<39.9 pg/mL,5.00-45.00 pg/mL,7.63-42.60 pg/mL,6.00-27.00 pg/mL A27 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Estrogen, Total, Serum 0562-9 Alternate Name: ESTROGENS,TOT.SER. Preferred Specimen: 3 mL SST Tube CPT Code: 82672 (1) Alternate Specimen: Microtainer - Pediatric Red,Microtainer - Pediatric SST,Aliquot Tube-Serum,Red Top,Green top,Microtainer - Pediatric Green Top,Aliquot Plasma Heparinized-green top,Aliquot Tube-Plasma Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 5 days Factor V (R2) Polymorphism Alternate Name: FACTOR V (R2) Methodology: PCR Preferred Specimen: 4 mL Yellow top- ACD Alternate Specimen: 4 mL Lavender top- EDTA Specimen Comment: Sendout Turn Around Time: 18 days Ref Range: See Report 5727-3 CPT Code: 81400 (1) Factor V Mutation (Leiden) 5726-5 Alternate Name: FACTOR V MUTATION Methodology: PCR Preferred Specimen: 4 mL Lavender top- EDTA CPT Code: 81241 (1) Alternate Specimen: Microtainer - Pediatric Lavender,4 mL Yellow top- ACD Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 5 days Clinical Indication: This test is used to detect mutations in clotting factor V that may lead to an increased risk for deep vein thrombosis and miscarriage. Ref Range: See Report Ferritin, Serum 0088-5 Alternate Name: FERRITIN Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 82728 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: This test measures the level of ferritin, a primary iron storage in the body. Low levels of ferritin are indicative of iron deficiency, a cause of anemia. Ref Range: 10-291 ng/mL,22-322 ng/mL,See Below ng/mL,50-200 ng/mL,7-140 ng/mL FLT3 Mutation Analysis 5178-9 Alternate Name: FLT-3 MUTATION Methodology: PCR Preferred Specimen: 5 mL Peripheral Blood - Lavender Top CPT Code: 81245 (1), 81479 (1) Alternate Specimen: 3 mL Bone Marrow - Green Top,Peripheral Blood - Green Top,3 mL Bone Marrow - Lavender Top Specimen Comment: If submitting bone marrow, 2 ml is required. Performed at LabPMM for NY and NON-NY Storage Instruction: Refrigerate Turn Around Time: 3-7 days Clinical Indication: FLT3 (fms-like tyrosine kinase 3) is a tyrosine kinase receptor expressed on hematopoietic progenitor cells and is important in stem cell survival and differentiation. FLT3 mutation is a poor prognostic marker in AML. It also has additional therapeutic utility as a potential target for inhibitor therapy. Ref Range: See Report 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A28 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Folate, Serum 0090-1 Alternate Name: FOLIC ACID Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 82746 (1) Alternate Specimen: Aliquot Tube-Serum,Red Top,Microtainer - Pediatric SST,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Testing for folic acid is clinically useful to determine a possible cause of macrocytic anemia. Ref Range: >5.38 ng/mL,See Below ng/mL Follicle Stimulating Hormone (FSH) 0092-7 Alternate Name: FSH Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 83001 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: 1.5-12.4 mIU/mL,1.27-19.26 mIU/mL,See Below mIU/mL,1.4-18.1 mIU/mL Free Kappa & Lambda Light Chain (serum) Alternate Name: KAPPA/LAMBDA LIGHT C Methodology: Immunoturbidometric Preferred Specimen: 1 mL SST Tube Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 3 days Components: KAPPA FREE LIGHT CHAIN, LAMBDA FREE LIGHT CHAIN Clinical Indication: Useful in monitoring of Plasma Cell Myeloma. Ref Range: See Report mg/L 3893-5 CPT Code: 83520 (2) GenArray Molecular Karyotyping 5306-6 Alternate Name: ARRAY CGH ANALYSIS Methodology: Array CGH Preferred Specimen: 2 mL Bone Marrow - Lavender Top CPT Code: 81406 (1) Alternate Specimen: 5 mL Peripheral Blood - Lavender Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 7-10 days Clinical Indication: Array CGH identifies aneusomal DNA copy number alterations (losses and gains of DNA) in myeloid, lymphoid, and plasma cell neoplasms. Copy number changes have significant diagnostic, prognostic, and therapeutic implications. Array CGH offers superior resolution to that of conventional cytogenetics and FISH for copy number change detection. In addition, Array CGH does not require metaphase analysis (dividing cells), overcoming the inherent limitation of required cell growth for lymphoid-derived neoplasms by cytogenetic analysis. Germ Cell Tumor IHC Panel 5194-6 Alternate Name: GERM CELL TUMOR, IHC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1), G0462 (8) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Useful for assessment of germ cell tumors. The components of this panel include: AFP, CAM 5.2, CD30, CD117, HCG, Oct 3/4, PLAP, Podoplanin and SALL4. Ref Range: See Report A29 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 GIST Profile 5175-5 Alternate Name: GIST PROFILE Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1), G0462 (5) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Useful for assessment of gastrointestinal stromal tumors. The components of this panel include: Actin, CD34, CD117, DOG-1, S100 and SMA. Ref Range: See Report Gonorrhea (GC), Urine, Probetec Alternate Name: N.GONOR.AMP.DNA Methodology: PCR Preferred Specimen: Urine Tube BD Alternate Specimen: Urine Cup,Urine tube without preservative Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: Negative 2666-6 CPT Code: 87591 (1) Haptoglobin, Serum 0514-0 Alternate Name: HAPTOGLOBIN Methodology: Immunoturbidometric Preferred Specimen: 1 mL SST Tube CPT Code: 83010 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Avoid hemolysis Storage Instruction: Refrigerate Turn Around Time: 2 days Clinical Indication: Used to assess intravascular hemolysis Ref Range: 30-200 mg/dL Helicobacter pylori, IgA 1766-5 Alternate Name: H.PYLORI Ab.,IgA Methodology: Enzyme Linked Immunoabsorbance Preferred Specimen: 1 mL SST Tube CPT Code: 86677 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 3 days Clinical Indication: The detection of high titer of antibody IgA to Helicobacter pylori (H. pylori) is used to screen for active infection and cause of gastrointestinal disease. The presence of high titers of IgA only suggests infection and should be confirmed with other tests. High titers of both IgA and IgG antibodies to H. pylori may be considered to represent a chronic active infection. Ref Range: See Below Helicobacter pylori, IgG 1765-7 Alternate Name: H.PYLORI Ab.,IgG Methodology: Enzyme Linked Immunoabsorbance Preferred Specimen: 1 mL SST Tube CPT Code: 86677 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 3 days Clinical Indication: The detection of high titer of antibody IgG to Helicobacter pylori (H. pylori) is used to screen for active infection and cause of gastrointestinal disease. High titers of both IgA and IgG antibodies to H. pylori may be considered to represent a chronic active infection. Ref Range: See Below 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A30 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Helicobacter pylori, IgM 7736-2 Alternate Name: H.PYLORI Ab.,IgM Methodology: Enzyme Linked Immunoabsorbance Preferred Specimen: 1 mL SST Tube CPT Code: 86677 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 3 days Clinical Indication: The detection of IgM may be useful to determine causes of gastritis. Ref Range: See Below Hemoglobin A1C Alternate Name: Hemoglobin A1c Methodology: Immunoturbidometric Preferred Specimen: 0.5 mL Lavender top- EDTA Alternate Specimen: Microtainer - Pediatric Lavender Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Diabetic monitoring. Ref Range: <5.7 % 0102-4 CPT Code: 83036 (1) Hemoglobin Fractionation, HPLC 0216-2 Alternate Name: HEMOGLOBIN FRACTIONATION (HPLC) Methodology: High Pressure Liquid Chromatography Preferred Specimen: 1 mL Lavender top- EDTA CPT Code: 83021 (1) Alternate Specimen: Microtainer - Pediatric Lavender Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 2 days Components: Hb A, Hb A2, Hb F, Hb S, Hb C, Hb OTHER Clinical Indication: Assesses for Beta-thalassemia and sickling hemoglobinopathies. Ref Range: Hepatic Function Panel 3422-3 Alternate Name: HEPATIC FUNCTION Preferred Specimen: 2 mL SST Tube CPT Code: 80076 (1) Alternate Specimen: Aliquot Tube-Serum,Microtainer - Pediatric SST Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Components: Total Protein, Albumin, Bilirubin, Total, Alk Phos, AST, Bilirubin, Direct, ALT Clinical Indication: For evaluating liver function. Hepatocellular vs. Cholangiocarcinoma vs. Metastasis IHC Panel 5193-8 Alternate Name: HEPATOCELVCHOLANGVMETAS/IHC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1), G0462 (10) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Differential diagnosis between Hepatocellular, Cholangiocarcinoma and GI/pulmonary metastasis. The components of this panel include: AFP, CA19.9, CAM 5.2, CDX2, CEAm, CK7, CK20, Glypican-3, Hepatocyte, PODXL-1 and TTF-1. Supplementary IHC may be necessary for definitive characterization if metastatic disease is identified. Ref Range: See Report A31 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 HER2 by IHC 5171-4 Alternate Name: Her-2/Neu, IHC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361 (1) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: HER2 by IHC is used to set treatment strategics in breast carcinoma. Results may predict response to tyrosine kinase inhibitor therapy. Ref Range: See Report HER2 by FISH 5262-1 Alternate Name: HER-2/Neu,FISH Methodology: FISH Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88367 (2) Alternate Specimen: Unstained Slide Specimen Comment: Please include specimen collection date on requisition. This comes in block from client with surgical number imprint. This comes in block from client with surgical number imprint. Storage Instruction: Room Temp Turn Around Time: 3-5 days Clinical Indication: HER2 by FISH is used to determine prognosis and for predictive response to tyrosine kinase inhibitor therapy. FISH is commonly used to confirm borderline IHC results and/or as an additional confirmation of HER2 status. Ref Range: See Report HER2 by FISH - Gastric/GEJ A427-7 Alternate Name: HER2 FISH-GASTRIC+GEJ Methodology: FISH Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88367 (2) Alternate Specimen: Unstained Slide Specimen Comment: Storage Instruction: Room Temp Turn Around Time: 3-5 days Clinical Indication: HER2 by FISH is used to predict response to tyrosine kinase inhibitor therapy. FISH is often used as secondary confirmation for borderline 2+ cases. Ref Range: See Report HER2 by FISH for Gastric/GEJ- TC Only A428-5 Alternate Name: HER2 FISH TC-GAS.+GEJ Methodology: FISH Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88367-TC (2) Alternate Specimen: Unstained Slide Specimen Comment: Please include specimen collection date on requisition. Please write surgical number on block and on requisition. Provide fixation time on requisition as well Storage Instruction: Room Temp Turn Around Time: 3-5 days Clinical Indication: HER2 by FISH is used to predict response to tyrosine kinase inhibitor therapy. FISH is often used as secondary confirmation for borderline 2+ cases. HER2 by IHC - Reflex +2 to HER2 by FISH 5428-8 Alternate Name: HER-2 NEU, IHC w/reflex to FISH Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361 (1) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 3-5 days Clinical Indication: HER2 by IHC is used to set treatment strategics in breast carcinoma. Results may predict response to tyrosine kinase inhibitor therapy. Borderline 2+ cases are automatically reflexed to FISH. Ref Range: See Report 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A32 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 HER2 by IHC in Gastric/Gastroesophageal Carcinoma Alternate Name: HER2 BY IHC GI/ESO CARCINOMA Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: To assess for the indication of trastuzumab. Ref Range: See Report A972-2 CPT Code: G0461 (1) HER2 by IHC- TC Only 5405-6 Alternate Name: HER-2 NEU, IHC (TC ONLY) Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361-TC (1) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: HER2 by IHC is used to determine if patient is a candidate for trastuzumab therapy. Results may predict response to tyrosine kinase inhibitor therapy. HER2 FISH- TC Only 5259-7 Alternate Name: AUTOMATED HER2 FISH TC ONLY Methodology: FISH Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88367-TC (2) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 3-5 days Clinical Indication: HER2 by FISH is used to determine prognosis and for predictive response to tyrosine kinase inhibitor therapy. FISH is commonly used to confirm borderline IHC results and/or as an additional confirmation of HER2 status. Hereditary Hemochromotosis (HFE): C282Y, H63D, S65C 3420-7 Alternate Name: HEMOCHROMATOSIS DNA Methodology: PCR Preferred Specimen: 5 mL Peripheral Blood - Lavender Top CPT Code: 81256 (1) Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 3-4 days Clinical Indication: Interrogation of genes, C282Y, H63D, and S65C, that assess risk for hereditary hemochromotosis (HFE). HFE is a common autosomal recessive disorder leading to the excessive accumulation of iron in the parenchymal organs. Ref Range: See Report HIV-1/HIV-2 Antibody Screen Alternate Name: HIV 1/2 ANTIBODY Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 86703 (1) Alternate Specimen: Microtainer - Pediatric SST,Red Top,Microtainer - Pediatric Red,Aliquot Tube-Serum Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: Negative A33 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. 0360-8 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 HLA-B27 0375-6 Alternate Name: HLA-B27 Methodology: Flow Cytometry Preferred Specimen: 5 mL Green top CPT Code: 86812 (1) Alternate Specimen: Lavender top- EDTA,Yellow top- ACD,Microtainer - Pediatric Green Top,Microtainer - Pediatric Lavender Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 3 days Ref Range: Negative Hodgkin Lymphoma IHC Panel 5101-1 Alternate Name: NON-HODGKINS V. HODGKINS Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1), G0462 (8) Alternate Specimen: Unstained Slide Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Differential diagnosis between NHL and Hodgkin Lymphoma (HL). The components of this panel include: CD3, CD15, CD20, CD30, CD45, CD79a, EBV, Fascin and PAX-5. HPV High by ISH 8714-8 Alternate Name: HPV HIGH by ISH Methodology: In Situ Hybridization Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88365 (1) Alternate Specimen: Unstained Slide Specimen Comment: Unstained slides on Fisherbrand Superfrost PLUS microscope slides ONLY Turn Around Time: 1 days Clinical Indication: Useful for assessment of high risk Human Papillomavirus Ref Range: Negative HPV High by ISH- TC Only 8689-2 Alternate Name: HPV HIGH by ISH STAIN ONLY Methodology: In Situ Hybridization Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88365-TC (1) Alternate Specimen: Unstained Slide Specimen Comment: Unstained slides on Fisherbrand Superfrost PLUS microscope slides ONLY Turn Around Time: 1 days Clinical Indication: Useful for assessment of high risk Human Papillomavirus HPV High/Low by ISH- TC Only 8696-7 Alternate Name: HPV HIGH/LOW by ISH STAIN ONLY Methodology: In Situ Hybridization Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88365-TC (2) Alternate Specimen: Unstained Slide Specimen Comment: Unstained slides on Fisherbrand Superfrost PLUS microscope slides ONLY Turn Around Time: 1 days Clinical Indication: Useful for assessment of low and high risk Human Papillomavirus 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A34 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 HPV High/Low Risk by ISH 3412-4 Alternate Name: HPV HIGH/LOW BY ISH Methodology: In Situ Hybridization Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88365 (2) Alternate Specimen: Unstained Slide Specimen Comment: Unstained slides on Fisherbrand Superfrost PLUS microscope slides ONLY Turn Around Time: 1 days Clinical Indication: Useful for assessment of low and high risk Human Papillomavirus Ref Range: Negative Human Chorionic Gonadotropin (HCG), Quantitative, Tumor Marker 1201-3 Alternate Name: HCG,QUANT.(TUMOR MK) Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 84702 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: <2.0 mIU/mL,<10.0 mIU/mL,See Below mIU/mL IgH/TCR-GAMMA by PCR 5080-7 Alternate Name: DNA PROBE LYMPHOCYTE Methodology: PCR Preferred Specimen: 2 mL Bone Marrow - Lavender Top CPT Code: 81342 (1) Alternate Specimen: 5 mL Peripheral Blood - Lavender Top,Tissue in RPMI Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required Storage Instruction: Refrigerate Turn Around Time: 1-2 days Components: TCR-gamma, PCR, ICH, PCR Clinical Indication: IgH assesses B-cell clonality, while TCR-gamma is used to assess for T-cell clonality. IgVH Mutation Analysis 5223-3 Alternate Name: IGVH MUTATION ANALYSIS Methodology: PCR Preferred Specimen: 5 mL Peripheral Blood - Lavender Top CPT Code: 81263 (1) Alternate Specimen: 2 mL Bone Marrow - Lavender Top,Peripheral Blood - Green Top Specimen Comment: If submitting bone marrow place bone marrow into tube, label with patient's name. Send in bone marrow kit. Storage Instruction: Refrigerate Turn Around Time: 3-4 days Clinical Indication: Prognostic marker for patients with CLL. Hypermutated IgVH is a favorable prognostic indicator in CLL. Ref Range: See Report Immunofixation, Serum 0413-5 Alternate Name: IMMUNOFIXATION,SERUM Preferred Specimen: 1 mL SST Tube CPT Code: 86334 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Replaces Immunoelectrophoresis Storage Instruction: Refrigerate Turn Around Time: 4 days Clinical Indication: Immunofixation is used to characterize an abnormal population of monoclonal immunoglobulin proteins, or an M-spike, usually associated with a plasma cell myeloma. Ref Range: Negative A35 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Immunofixation, Urine, Random 1644-4 Alternate Name: IMMUNOFIXATION, URINE Methodology: Electrophoresis Preferred Specimen: 9 mL Urine Cup CPT Code: 86335 (1) Alternate Specimen: Urine Container - 24hr,Urine tube without preservative,Urine Urinalysis Tube - Yellow,Urine Cup 24 hour,Urine Tube 24 hour Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 2 days Clinical Indication: Immunofixation is used to characterize an abnormal population of monoclonal immunoglobulin proteins and/or free light chains (Bence Jones proteins) in the urine, usually associated with plasma cell myeloma. Ref Range: Negative Immunoglobulins, Serum 0520-7 Alternate Name: IMMUNOGLOBULINS, SER Methodology: Immunoturbidometric Preferred Specimen: 1 mL SST Tube CPT Code: 82784 (3) Alternate Specimen: Red Top,Microtainer - Pediatric Red,Microtainer - Pediatric SST,Aliquot Tube-Serum Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Components: IgG, SERUM, IgM, SERUM, IgA, SERUM Iron + TIBC Alternate Name: IRON + TIBC Preferred Specimen: 2 mL SST Tube Alternate Specimen: Microtainer - Pediatric SST,Aliquot Tube-Serum Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Components: Iron, TIBC Clinical Indication: Assess iron stores and transferrin. See ferritin test. Ref Range: See Report 0250-1 CPT Code: 83540 (1), 83550 (1) JAK2 Exon 12 5307-4 Alternate Name: JAK-2 Exon 12 Methodology: PCR Preferred Specimen: 2 mL Bone Marrow - Lavender Top CPT Code: 81403 (1) Alternate Specimen: 5 mL Peripheral Blood - Lavender Top,Peripheral Blood - Green Top,Bone Marrow - Green Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 4 days Clinical Indication: Useful for assessment of Polycythemia vera in patients who are JAK2 V617F-negative. Ref Range: See Report JAK2 V617F 5157-3 Alternate Name: JAK-2 V617F MUT. ANALYSIS Methodology: PCR Preferred Specimen: 2 mL Bone Marrow - Lavender Top CPT Code: 81270 (1) Alternate Specimen: 5 mL Peripheral Blood - Lavender Top,Peripheral Blood - Green Top,Bone Marrow - Green Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 3 days Clinical Indication: Assess for non-CML Chronic Myeloproliferative Neoplasms (Essential Thrombocythemia, Polycythemia vera, Myelofibrosis). Ref Range: See Report 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A36 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Ki-67 by IHC Alternate Name: Ki-67, IHC MANUAL Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Assess tumor cell proliferation. Ref Range: See Report 5152-4 CPT Code: 88361 (1) Ki-67 by IHC- TC Only Alternate Name: KI-67 IMAGED Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue Alternate Specimen: Unstained Slide Specimen Comment: Storage Instruction: Room Temp Turn Around Time: 1 days Clinical Indication: To assess for proliferation in breast cancer. A346-9 CPT Code: 88361-TC (1) KIT (D816V) by PCR 5179-7 Alternate Name: C-KIT (CD117) Methodology: PCR Preferred Specimen: 2 mL Bone Marrow - Lavender Top CPT Code: 81402 (1) Alternate Specimen: 5 mL Peripheral Blood - Lavender Top,Peripheral Blood - Green Top,Bone Marrow - Green Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 3-4 days Clinical Indication: Systemic mastocytosis is characterized by the infilitration of clonal mast cells in the bone marrow, tissue, liver, and skin. Mutational testing for KIT D816V is a diagnostic tool for systemic mastocytosis because the majority of confirmed diagnoses harbor this mutation. Bone marrow evaluation is the primary diagnostic tool for systemic mastocytosis and provides the most reliable prognosis. Patients that harbor the KIT mutation exhibit resistance to tyrosine kinase inhibitor therapy, such as imatinib. When KIT is mutated in the presence of RUNX1 the patient prognosis is unfavorable. Ref Range: See Report KIT/PDGFRA for GIST by PCR A344-4 Alternate Name: C-KIT/PDGFRA (GIST) Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81404 (1) Alternate Specimen: Unstained Slide,Shavings Specimen Comment: Please write surgical number on block and on requisition. Provide fixation time on requisition as well. Storage Instruction: Room Temp Turn Around Time: 5-7 days Clinical Indication: KIT mutations in exons 9 and 11 are present in ~85% of GIST patients.This test is helpful to determine patient response to imatinib. Patients with PDGFRA mutations are more likely to respond to imatinib while secondary KIT mutations in exons 13, 14, 17, and 18 are common in patients with acquired imatinib resistance. Ref Range: See Report KRAS 5288-6 Alternate Name: K-RAS GENE MUTATION Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81275 (1), 88381 (1) Alternate Specimen: Unstained Slide,Shavings Specimen Comment: Turn Around Time: 2-3 days Clinical Indication: Assessment for resistance to tyrosine kinase inhibitor therapy, used primarily in lung and colon cancer. Ref Range: See Report A37 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 KRAS if Negative Reflex to BRAF 5891-7 Alternate Name: GP/K-RAS IF NEG. RFLX TO BRAF Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81275 (1), 88381 (1) Alternate Specimen: Unstained Slide,Shavings Specimen Comment: Turn Around Time: 3-4 days Clinical Indication: Assessment for resistance to tyrosine kinase inhibitor therapy used in colon cancer. Ref Range: See Report Lactate Dehydrogenase (LDH), Serum 0117-2 Alternate Name: LD Methodology: UV Preferred Specimen: 2 mL SST Tube CPT Code: 83615 (1) Alternate Specimen: Microtainer - Pediatric SST,Aliquot Tube-Serum Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Helpful in the diagnostic and prognostic assessment for hematological malignancies. Ref Range: 135-225 U/L,120-246 U/L,135-214 U/L Lipid Panel Alternate Name: LIPID PANEL Preferred Specimen: 2 mL SST Tube Alternate Specimen: Microtainer - Pediatric SST,Aliquot Tube-Serum Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Components: Cholesterol, HDL CHOL., DIRECT, Triglycerides 0009-1 CPT Code: 80061 (1) Low-density lipoprotein (LDL) Direct Alternate Name: LIPOPROT. (LDL) DIRECT Methodology: Enzyme Immunoassay Preferred Specimen: 1 mL SST Tube Alternate Specimen: Microtainer - Pediatric SST,Aliquot Tube-Serum Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Risk factor for developing coronary artery disease (CAD). Ref Range: <100 mg/dL 2194-9 CPT Code: 83721 (1) Lung Adeno Reflex Dx B367-4 Alternate Name: LUNG ADENO RFX DX PANEL Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81275 (1), 88381 (1), 81235 (1), 88381 (1) Alternate Specimen: Unstained Slide Specimen Comment: FFPE:Indicate source. Label block and requisition with surgical number and pack in shipping kit Storage Instruction: Room Temp Turn Around Time: 5-7 days Clinical Indication: This reflex biomarker panel is useful to determine eligibility and response to targeted therapies. EGFR and KRAS with negative reflexes to ALK and ROS1 Ref Range: See Report 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A38 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Lung Adeno Reflex Panel: EGFR --> KRAS--> ALK P263-7 Alternate Name: LUNG ADENO REFLEX PANEL Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81235 (1), 88381 (1) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 5-7 days Components: EGFR BY PCR Clinical Indication: This reflex biomarker panel is useful to determine eligibility and response to targeted therapies. Lung Adenocarcinoma Targeted Therapy Profile B369-0 Alternate Name: EGFR RFX>ALK RFX>ROS1 Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81235 (1), 88381 (1) Alternate Specimen: Unstained Slide Specimen Comment: Storage Instruction: Room Temp Turn Around Time: 3-5 days Clinical Indication: This test is used for patients with non-small-cell lung cancer, primarily adenocarcinoma histology, to determine appropriateness of tyrosine kinase inhibitor therapy. CAP guidelines recommend EGFR in advanced stage adenocarcinoma regardless of sex, smoking history, and other clinical factors. Expert concensus opinion written in the CAP guidelines recommend EGFR testing for all stages of adenocarcinoma. EGFR with a negative reflex to ALK. If ALK is negative a reflex to ROS1 will be added. Ref Range: See Report Lung Histology IHC Panel A130-7 Alternate Name: SQUAMOS V. ADENOCARCINOMA Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88342 (5) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Classification of histology subtype (adenocarcinoma vs. squamous cell carcinoma) in patients with lung cancer. The components of this panel include: CK5/6, Napsin A, p40 and TTF-1. Ref Range: See Report Lung Profile: KRAS, EGFR, EML4-ALK, ROS1 B368-2 Alternate Name: KRAS,EFGR,EML4-ALK,ROS1 Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81275 (1), 88381 (1), 81235 (1), 88368 (4) Alternate Specimen: Unstained Slide Specimen Comment: FFPE: Indicate source. Label block and requisition with surgical number and pack in shipping kit. Storage Instruction: Room Temp Turn Around Time: 3-5 days Clinical Indication: This lung biomarker panel is useful to determine eligibility and response to targeted therapies. Ref Range: See Report Luteinizing Hormone (LH) Alternate Name: LH Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 83002 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: 1.7-8.6 mIU/mL,1.24-8.62 mIU/mL,See Below mIU/mL,1.5-9.3 mIU/mL A39 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. 0342-6 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Lyme Disease Antibody, Serum 0568-6 Alternate Name: LYME DISEASE Ab. Methodology: Enzyme Linked Immunoabsorbance Preferred Specimen: 1 mL SST Tube CPT Code: 86618 (1) Alternate Specimen: Microtainer - Pediatric SST,Aliquot Tube-Serum,Red Top,Microtainer - Pediatric Red Specimen Comment: Positive result will auto-reflex to LYME IgM-1615 at additional charge Storage Instruction: Refrigerate Turn Around Time: 2 days Clinical Indication: For determining antibodies to Borrelia burgdorferi, which causes Lyme disease. Ref Range: <0.91 Lymphoproliferative Disorder Analysis 5535-0 Alternate Name: CHRONIC FLOW PANEL B+T CELL Methodology: Flow Cytometry Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88184 (1), 88185 (17), 88189 (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Tissue in RPMI,Peripheral Blood - Lavender Top,Bone Marrow - Lavender Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Flow Cytometry is useful in the detection and diagnostic subclassification of lymphoma. It is specifically important in the subclassification of B-cell malignancies such as chronic lymphocytic leukemia, mantle cell lymphoma, lymphoplasmacytic lymphoma, follicle center and Burkitt's lymphoma, and plasmacytoma. Ref Range: See Report Lymphoproliferative Disorder Analysis (Technical Only) 5536-8 Alternate Name: CHRONIC FLOW PANEL (TC ONLY) Methodology: Flow Cytometry Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88184 (1), 88185 (17) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Tissue in RPMI,Peripheral Blood - Lavender Top,Bone Marrow - Lavender Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Flow Cytometry is useful in the detection and diagnostic subclassification of lymphoma. It is specifically important in the subclassification of B-cell malignancies such as chronic lymphocytic leukemia, mantle cell lymphoma, lymphoplasmacytic lymphoma, follicle center and Burkitt's lymphoma, and plasmacytoma. Lynch Syndrome Reflex Screening B366-6 Alternate Name: BRAF RFLX NEG. TO MLH1 Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81210 (1), 88381 (1) Alternate Specimen: Unstained Slide Specimen Comment: Please attach MSI results. Test cannot be performed without MSI results. Source and pathology report is required. This comes in block from client with surgical number imprint. Storage Instruction: Room Temp Turn Around Time: 5 days Clinical Indication: Testing algorithm designed to rule out Lynch Syndrome. Ref Range: See Report 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A40 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 MDS FISH Panel 5281-1 Alternate Name: +8,-5/5q-,-7/7q-,20q-, FISH Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367 (4) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Please include specimen collection date on requisition Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: Useful for assessment of primary myeloid disorders, including MDS. Patients with 5q- are eligible for treatment with lenalidomide. Ref Range: See Report MDS FISH Panel- TC Only P960-8 Alternate Name: MDS FISH PANEL- TC ONLY Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367-TC (4) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition Storage Instruction: Refrigerate Turn Around Time: 3-5 days Components: -7/7Q- BY FISH-TC ONLY, -5/5Q- BY FISH-TC ONLY, TRISOMY 8 BY FISH-TC, 20Q12 BY FISH-TC ONLY Clinical Indication: Useful for assessment of primary myeloid disorders, including MDS. Patients with 5q- are eligible for treatment with lenalidomide. MET by FISH B335-1 Alternate Name: MET BY FISH GLOBAL Methodology: FISH Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88368 (2) Alternate Specimen: Unstained Slide Specimen Comment: Please write surgical number on block and on requisition. Provide fixation time on requisition as well. Storage Instruction: Room Temp Turn Around Time: 7-10 days Clinical Indication: Detects MET amplification that has prognostic and therapeutic implications in various solid tumors, such as NSCLC. MET by FISH - TC Only B336-9 Alternate Name: MET BY FISH-TECH ONLY Methodology: FISH Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88367 (2) Alternate Specimen: Unstained Slide Specimen Comment: Storage Instruction: Room Temp Turn Around Time: 3-5 days Clinical Indication: Detects MET amplification that has diagnostic and prognostic utility for various solid tumors, such as NSCLC. MET by IHC A612-4 Alternate Name: MET BY IHC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88342 Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: To assess for MET protein overexpression that may drive cancer proliferation in epithelial cancers such as NSCLC. Ref Range: See Report A41 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Metastatic Carcinoma (Breast, Colon) - Lymph Node 5124-3 Alternate Name: COLON CANCER/LYMPH NODES Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Assess for nodal metastatic carcinoma with antibody AE1/AE3. Three levels are examined. Ref Range: See Report Metastatic Melanoma - Lymph Node 5126-8 Alternate Name: MELANOMA/LYMPH NODES Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1), G0462 (2) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Assess for nodal metastatic carcinoma. The components of this panel include: S100, HMB45 and Melan A. Ref Range: See Report Microsatellite Instability (MSI-H) by PCR 3371-2 Alternate Name: MICRO SATELLITE INSTABILITY Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81301 (1), 88381 (1) Alternate Specimen: Unstained Slide,Shavings Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: MSI by PCR is useful to detect deficiencies in mismatch repair genes. Stage II colorectal cancer patients with Microsatellite unstable tumors typically do not respond favorably to chemotherapy. An alternative test is MSI by IHC. Ref Range: See Report Minimal Residual Disease for CLL/SLL 5155-7 Alternate Name: RESIDUAL CLL/SLL ANALYSIS Methodology: Flow Cytometry Preferred Specimen: 5 mL Peripheral Blood - Green Top CPT Code: 88184 (1), 88185 (8), 88188 (1) Alternate Specimen: 2 mL Bone Marrow - Green Top Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 24 hours Clinical Indication: Flow Cytometry panel that focuses on B-cell markers used to assess MRD in CLL/SLL patients. Ref Range: See Report Mismatch Repair Protein (MMR) for Lynch Syndrome by IHC A943-3 Alternate Name: MSI BY IHC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1), G0462 (3) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: MSI by IHC is useful to detect deficiencies in mismatch repair genes. Stage II colorectal cancer patients with Microsatellite unstable tumors typically do not respond favorably to chemotherapy. Mismatch repair protein defect(s) by IHC is also an initial screening test for Lynch syndrome. An alternative test is MSI by PCR. The components of this panel include: MLH1, MSH2, MSH6 and PMS2. Ref Range: See Report 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A42 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Mismatch Repair Protein (MMR) for Lynch Syndrome by IHC- TC Only A944-1 Alternate Name: MSI BY IHC, TC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461-TC (1), G0462-TC (3) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: MSI by IHC is useful to detect deficiencies in mismatch repair genes. Stage II colorectal cancer patients with Microsatellite unstable tumors typically do not respond favorably to chemotherapy. Mismatch repair protein defect(s) by IHC is also an initial screening test for Lynch syndrome. An alternative test is MSI by PCR. The components of this panel include: MLH1, MSH2, MSH6 and PMS2. MLH1 Promoter Hypermethylation A313-9 Alternate Name: MLH-1 PROMO.METHYLATION Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81479 (1) Alternate Specimen: Unstained Slide,Shavings Specimen Comment: Please attach MSI results. Test cannot be performed without MSI results. Source and pathology report is required. Turn Around Time: 4-5 days Clinical Indication: Hypermethylation test used to help differentiate colon tumors between those with sporadic vs hereditary lineage. This test should only be used after a mismatch repair deficiency has been established for MLH1 (IHC or PCR). Ref Range: See Report MPL515 5272-0 Alternate Name: MPL515 MUTATION ANALYSIS Methodology: PCR Preferred Specimen: 2 mL Bone Marrow - Lavender Top CPT Code: 81402 (1) Alternate Specimen: 5 mL Peripheral Blood - Lavender Top,Bone Marrow - Green Top,Peripheral Blood - Green Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 2-3 days Clinical Indication: Assessment of JAK2 V617F-negative Chronic Myeloproliferative Neoplasms (ET, Myelofibrosis) Ref Range: No Mutation MTHFR A1298C Alternate Name: MTHFR A1298C Methodology: PCR Preferred Specimen: 1 mL Lavender top- EDTA Alternate Specimen: Microtainer - Pediatric Lavender Specimen Comment: Storage Instruction: Room Temp Turn Around Time: 5 days Ref Range: No Mutation 5765-3 CPT Code: 81291 (1) MTHFR C677T Gene Mutation Alternate Name: MTHFR C677T Methodology: PCR Preferred Specimen: 4 mL Lavender top- EDTA Alternate Specimen: Microtainer - Pediatric Lavender Specimen Comment: Storage Instruction: Room Temp Turn Around Time: 5 days Ref Range: No Mutation A43 5764-6 CPT Code: 81291 (1) 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Multiple Myeloma FISH Panel 5282-9 Alternate Name: FGFR3,RB1,BCL1,P53,1q21 Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367 (2) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Please include specimen collection date on requisition. CD138 magnetic enrichment of plasma cells is available (submit 1.5 cc of marrow). Storage Instruction: Refrigerate Turn Around Time: 3-5 days Components: BCL1,t(11;14),FISH, P53 by FISH, IGH/MAF Clinical Indication: FISH offers a sensitive method for the detection of chromosomal abnormalities, often found in plasma cell myeloma. Chromosomal abnormalities are important prognostic indicators. All 6 FISH probes are recommended by the International Myeloma Working Group. Ref Range: See Report Multiple Myeloma FISH Panel-TC Only P961-6 Alternate Name: M. MYELOMA FISH PANEL-TC ONLY Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367 (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Components: 13Q14 BY FISH-TC ONLY, T(11;14)+11 BY FISH-TC, 17P13 BY FISH-TC ONLY, T(4;14) BY FISH-TC ONLY, 1Q21 BY FISHTC ONLY, IGH/MAF- TC Clinical Indication: FISH offers a sensitive method for the detection of chromosomal abnormalities, often found in plasma cell myeloma. Chromosomal abnormalities are important prognostic indicators. All 6 FISH probes are recommended by the International Myeloma Working Group. Multiple Myeloma IHC Panel 5579-8 Alternate Name: PLASMA CELL DYSCRASIA/MM Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1), G0462 (10) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Useful for assessment of multiple myeloma/ plasma cell myeloma. The components of this panel include: CD20, CD45, CD56, CD79a, CD138, Cyclin D1, IgA, IgG, IgM, Kappa and Lambda. Ref Range: See Report MYC/IGH by FISH 5027-8 Alternate Name: MYC/IGH, t(8;14), FISH Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88368 (2) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Tissue in RPMI,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 2 days Clinical Indication: Useful for assessment of Burkitt lymphoma. Ref Range: See Report 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A44 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 MYC/IGH: t(8;14) by FISH- TC Only B349-2 Alternate Name: MYC/IGH BY FISH-TC Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367-TC (2) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Tissue in RPMI,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: Useful for assessment of Burkitt lymphoma. Myeloid & Lymphoid Analysis (Short Panel) - TC Only B338-5 Alternate Name: MYELOID & LYMPHOID SH.PNL-TC Methodology: Flow Cytometry Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88181 (1), 88185 (13) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Tissue in RPMI,Peripheral Blood - Lavender Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Room Temp Turn Around Time: 1 days Clinical Indication: This flow cytometry test is similar in clinical use to the expanded Acute and Lymphoid panel (5515) but utilizes less antibodies and is less comprehensive in scope. Ref Range: See Report Myeloid and Lymphoid Short Panel B271-8 Alternate Name: MYELOID/LYMP. SHORT PAN Methodology: Flow Cytometry Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88184 (1), 88185 (13), 88188 (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Tissue in RPMI,Peripheral Blood - Lavender Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Room Temp Turn Around Time: 1 days Clinical Indication: This flow cytometry test is similar in clinical use to the expanded Acute and Lymphoid panel (5515) but utilizes less antibodies and is less comprehensive in scope. Neuroendocrine Neoplasm IHC Panel 5195-3 Alternate Name: NEUROENDOCRINE NEOPLASM, IHC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1), G0462 (5) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Useful for assessment of neuroendocrine neoplasms. The components of this panel include: CAM 5.2, CD56, Chromogranin, Ki-67, Synaptophysin and TTF-1. Ref Range: See Report Non-Automated UroVysion 6274-5 Alternate Name: MANUAL URO-VYSION by FISH Methodology: FISH Preferred Specimen: 50 mL Voided Urine - Urocyte Collection Kit CPT Code: 88120 (1) Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: The test is useful for monitoring for tumor recurrence in patients with a history of urothelial carcinoma involving the bladder or upper urinary tract and for assessing patients with hematuria for urothelial carcinoma. Ref Range: See Report A45 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 OneCheck Hematopathology 5500-4 Alternate Name: ONECHECK HEMATOPATHOLOGY Preferred Specimen: Bone Marrow Core in Formalin CPT Code: 99999 Alternate Specimen: Bone Marrow - Green Top,Bone Marrow - Clot in Formalin,Stained Slides,Bone Marrow - Lavender Top Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 7 days Clinical Indication: Comprehensive hematopathology diagnostic workup with appropriate tests selected by GenPath hematopathologists. OneCheck Plus GenArray A500-1 Alternate Name: ONE CHECK PLUS Preferred Specimen: 2 mL Bone Marrow - Lavender Top CPT Code: 99999 Alternate Specimen: Bone Marrow Core in Formalin,Bone Marrow - Clot in Formalin,Slides,Green Aspirate,Peripheral Blood - Lavender Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 10 days Clinical Indication: Comprehensive hematopathology diagnostic workup with appropriate tests selected by GenPath hematopathologists. Array CGH analysis will be run as part of this assessment. OnkoMatch + for Lung, if ALK negative reflex to ROS1 Alternate Name: ONKOMATCH+LUNG,ALK NEG> Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue Q429-3 CPT Code: 81210 (1), 81235 (1), 81275 (1), 81323 (1), 88368 (2), 88381 (1) Alternate Specimen: H & E SLIDE,Unstained Slide Specimen Comment: Storage Instruction: Room Temp Turn Around Time: 5-7 days Components: EGFR EXON 19 DELETION, ONKOMATCH, EML4/ALK Clinical Indication: This test is utilized to determine available genetic targets in lung adenocarcinoma for personalized medicine therapy. OnkoMatch Tumor Genotyping A635-5 Alternate Name: ONKOMATCH TUMOR GENOTYP Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81210 (1), 81235 (1), 81275 (1), 81323 (1) Alternate Specimen: Unstained Slide,H & E SLIDE,Shavings Specimen Comment: Turn Around Time: 5-7 days Components: ONKOMATCH, EGFR EXON 19 DELETION Clinical Indication: To assess a patient's solid tumor for 14 oncogenes across 68 mutational hotspots that may be treated with targeted therapies. OnkoMatch Tumor Genotyping + for Lung Alternate Name: ONKOMATCH PLUS FOR LUNG Methodology: PCR Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue A642-1 CPT Code: 81210 (1), 81235 (1), 81275 (1), 81323 (1), 88368 (2), 88381 (1) Alternate Specimen: Unstained Slide,H & E SLIDE,Shavings Specimen Comment: Turn Around Time: 5-7 days Components: ONKOMATCH, EGFR EXON 19 DELETION, EML4/ALK Clinical Indication: This test is utilized to determine available genetic targets in lung cancer for personalized medicine therapy. 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A46 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 p53 by IHC 5153-2 Alternate Name: p53-TUMOR SUPP.GENE Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361 (1) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: This protein induces cell cycle arrest or apoptosis in response to sublethal or severe DNA damage, respectively, by differential transcription of target genes and through transcription-independent apoptotic functions. Associated with aggressive forms of breast cancer and other malignancies. Ref Range: See Report p53 by IHC- TC Only A347-7 Alternate Name: P53 IMAGED Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88361-TC (1) Alternate Specimen: Unstained Slide Specimen Comment: Storage Instruction: Room Temp Turn Around Time: 1 days Clinical Indication: This protein induces cell cycle arrest or apoptosis in response to sublethal or severe DNA damage, respectively, by differential transcription of target genes and through transcription-independent apoptotic functions. Associated with aggressive forms of breast cancer. Paroxysmal Nocturnal Hemoglobinuria (PNH) Test Alternate Name: PAROX.NOCTURNAL HEM. Methodology: Flow Cytometry Preferred Specimen: 5 mL Peripheral Blood - Lavender Top Alternate Specimen: 5 mL Peripheral Blood - Green Top,Lavender top- EDTA Specimen Comment: Submit within 24hrs of collection, time sensitive Storage Instruction: Room Temp Turn Around Time: 1 days Clinical Indication: Diagnostic for Paroxysmal Nocturnal Hemoglobinuria (PNH). Ref Range: See Report 5564-0 CPT Code: 88184 (1), 88185 (6), 88187 (1) Pathology Peripheral Smear Review 5106-0 Alternate Name: PERIPHERAL SMEAR Methodology: Microscopic Examination Preferred Specimen: Lavender top- EDTA CPT Code: 85060 (1) Alternate Specimen: Lavender top- EDTA,Microtainer - Pediatric Lavender,Green top,Microtainer - Pediatric Green Top,Light blue top Specimen Comment: Turn Around Time: 1 days Clinical Indication: Pathologist consultation on peripheral blood smear. Ref Range: See Report Pathology Slide Consultation Alternate Name: PATHOLOGY CONSULT Methodology: Morphology Preferred Specimen: Stained Slides CPT Code: 88321 (1) Alternate Specimen: H & E SLIDE,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Storage Instruction: Room Temp Turn Around Time: 1-2 days Clinical Indication: Slide consultation Ref Range: See Report A47 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. 5111-0 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 PDGFR alpha A430-1 Alternate Name: PDGFRA MUTATION Methodology: PCR Preferred Specimen: 5 mL Formalin-fixed, Paraffin-embedded Tissue CPT Code: 81404 (1) Alternate Specimen: 3 mL Bone Marrow - Lavender Top,6 mL Peripheral Blood - Lavender Top,Unstained Slide Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. See test code A344 for all Non-NY clients with Formalinfixed,Paraffin-embedded Tissue. Storage Instruction: Refrigerate Turn Around Time: 8 days Clinical Indication: GISTs with PDGFRA mutations (except D842V) are likely to respond to imatinib therapy. Ref Range: See Report PDGFR alpha/FIP1L1 by FISH 5182-1 Alternate Name: FIP1L1-PDGFRA Methodology: FISH Preferred Specimen: 5 mL Peripheral Blood - Green Top CPT Code: 88365 (1) Alternate Specimen: 2 mL Bone Marrow - Green Top,Formalin-fixed, Paraffin-embedded Tissue,Unstained Slide Specimen Comment: Please include specimen collection date on requisition Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: Mutations in the FIP1L1-PDGFRA gene may be useful in the diagnosis of a subset of chronic eosinophilic leukemias, termed hypereosinophliic syndrome (HES). Patients with HES have shown favorable response to tyrosine kinase inhibitor therapy, imatinib. FIP1L1-PDGFRA is also present in a subset of patients with systemic mastocytosis and these patients may respond to imatinib. In both HES and systemic mastocytosis, testing for FIP1L1-PDGFRA may be used for disease monitoring of patients on tyrosine kinase inhibitor therapy. Ref Range: See Report PDGFRbeta/TEL 5219-1 Alternate Name: PDGFRB/TEL,FISH Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88271 (2), 88275 (2), 88291 (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition. Ship with ice pack during warm weather. Storage Instruction: Refrigerate Turn Around Time: 5-7 days Clinical Indication: Useful in assessment of chronic myelomonocytic leukemia (CMML) and other hematologic disorders who may be responsive to imatinib mesylate. Ref Range: Negative Phosphates, Urine, 24 Hours 0411-9 Alternate Name: PHOSPHORUS,URINE 24 HR Preferred Specimen: 10 mL Urine Container - 24hr CPT Code: 81050 (2), 84105 (1) Alternate Specimen: Urine Cup 24 hour,Urine Tube 24 hour Specimen Comment: Adjust pH level with HCL preservatives. Record total volume on req. Storage Instruction: Refrigerate Turn Around Time: 3 days Plasma Cell Analysis 5573-1 Alternate Name: PLASMA CELL PANEL Methodology: Flow Cytometry Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88184 (1), 88185 (11), 88188 (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Peripheral Blood - Lavender Top,Bone Marrow - Lavender Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Flow Cytometry is useful in characterizing and distinguishing normal from neoplastic plasma cells based on the degree of surface antigen expression, presence of aberrant antigens, and detection of intracytoplasmic immunoglobulin heavy and light chains. Flow can assess for clonality but may underestimate plasma cell percentages. Ref Range: See Report 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A48 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Plasma Cell Analysis - TC Only 5574-9 Alternate Name: PLASMA CELL PANEL (TC ONLY) Methodology: Flow Cytometry Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88184 (1), 88185 (11) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Peripheral Blood - Lavender Top,Bone Marrow - Lavender Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Flow Cytometry is useful in characterizing and distinguishing normal from neoplastic plasma cells based on the degree of surface antigen expression, presence of aberrant antigens, and detection of intracytoplasmic immunoglobulin heavy and light chains. Flow can assess for clonality but may underestimate plasma cell percentages. PNH- TC Only Alternate Name: PAROX.NOCTURNAL HEM.TECH.ONLY Methodology: Flow Cytometry Preferred Specimen: 5 mL Peripheral Blood - Lavender Top Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Diagnostic for Paroxysmal Nocturnal Hemoglobinuria (PNH). 5185-4 CPT Code: 88184 (1), 88185 (6) Prostate Cancer/ Lymph Nodes Alternate Name: PROSTATE CANCER/LYMPH NODES Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Assess for nodal metastatic carcinoma. Ref Range: See Report 5122-7 CPT Code: G0461 (1) Prostate Specific Antigen (PSA) 0190-9 Alternate Name: PSA Total Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 84153 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: <4.00 ng/mL,<4.1 ng/mL Prostate Specific Antigen (PSA), Free and Total, Serum Alternate Name: PSA FREE/TOTAL Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 84153 (1), 84154 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Microtainer - Pediatric Red,Aliquot Tube-Serum Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Components: PSA Total, PSA, FREE A49 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. 2088-3 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Prostate Triple Stain 5097-1 Alternate Name: PROSTATE CARCINOMA PROFILE Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1), G0462 (2) Alternate Specimen: Unstained Slide Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: Useful for assessment of prostate carcinoma. The components of this panel include: CK903, p504S and p63. Ref Range: See Report Prostate Triple Stain- TC Only Alternate Name: PROSTATE CANCER (STAIN ONLY) Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: The components of this panel include: CK903, p504S and p63. Ref Range: See Report 5104-5 CPT Code: G0461-TC (1), G0462-TC (2) Protein Electrophoresis, Serum (SPEP) 0085-1 Alternate Name: PROTEIN ELECTROPHORESIS Preferred Specimen: 2 mL SST Tube CPT Code: 84155 (1), 84165 (7) Alternate Specimen: Microtainer - Pediatric SST,Aliquot Tube-Serum Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 2 days Components: Total Protein Clinical Indication: Serum proteins are separated into albumin, alpha, beta, and gamma globulins. Gamma globulins are assessed for a monoclonal spike (M protein) seen in plasma cell dyscrasias. Ref Range: See Report Prothrombin G20210A Mutation Alternate Name: PT G20210A MUTATION Methodology: PCR Preferred Specimen: 5 mL Lavender top- EDTA Alternate Specimen: Microtainer - Pediatric Lavender Specimen Comment: Storage Instruction: Room Temp Turn Around Time: 5 days Ref Range: See Report 5795-0 CPT Code: 81240 (1) Reactive Hyperplasia vs. Lymphoma (NHL) IHC Panel 5103-7 Alternate Name: REACT.HYPERPLASIAV.LYMPHOMA Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1), G4062 (12) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Rule out lymphoma vs. reactive lymphoid hyperplasia.The components of this panel include: BCL-2, BCL-6, CD3, CD5, CD10, CD20, CD23, CD43, CD79a, Cyclin D1, Kappa, Ki-67 and Lambda. Ref Range: See Report 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A50 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Reticulocyte Count 0141-2 Alternate Name: RETIC COUNT Preferred Specimen: 4 mL Lavender top- EDTA CPT Code: 85045 (1) Alternate Specimen: Microtainer - Pediatric Lavender Specimen Comment: Sample is stable at room temperature for 48 hours. Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: See Below %,2.12-3.47 %,1.55-2.70 %,0.99-1.82 %,0.82-1.45 %,0.98-1.94 %,0.90-1.49 %,0.48-2.10 % Rheumatoid Arthritis (RA) Factor 0796-3 Alternate Name: RF, QUANTITATIVE Methodology: Immunoturbidometric Preferred Specimen: 1 mL SST Tube CPT Code: 86431 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: <14 IU/mL ROS1 by FISH B334-4 Alternate Name: ROS1 BY FISH GLOBAL Methodology: FISH Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: 88368 (2) Alternate Specimen: Unstained Slide Specimen Comment: Please include specimen collection date on requisition. Please write surgical number on block and on requisition. Provide fixation time on requisition as well Storage Instruction: Room Temp Turn Around Time: 3-5 days Clinical Indication: Diagnostic for ROS1 rearrangements. Useful in determining patient's eligibility for crizotinib. Ref Range: See Report Sedimentation Rate, Erythrocyte (ESR) Alternate Name: ESR (SED-RATE) Preferred Specimen: Lavender top- EDTA Alternate Specimen: Microtainer - Pediatric Lavender Specimen Comment: ESR will be ran STAT if ordered in conjuction with CBC. Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: <21 mm/hr,<26 mm/hr 0086-9 CPT Code: 85651 (1) Small Round Cell Tumor IHC Panel 5177-1 Alternate Name: SMALL BLUE ROUND TUMORS, IHC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1), G0462 (12) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Useful for assessment of small round cell tumors. The components of this panel include: CAM 5.2, CK7, CK20, Chromogranin, Synaptophysin, CD99, CD45, CD56, S100, TTF-1, Vimentin, Desmin and NF. Ref Range: See Report A51 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Spindle Cell Neoplasm IHC Panel 5191-2 Alternate Name: SPINDLE CELL NEOPLASM, IHC Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1), G0462 (10) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: Useful for assessment of spindle cell neoplasms. The components of this panel include: Actin, AE1/AE3, CD34, CD68, CD117, Desmin, Factor XIIIa, Ki-67, S100, SMA and Vimentin. Ref Range: See Report Strep Screen, Group A, Beta-Hemolytic Alternate Name: GRP.A STREP SCREEN Methodology: LAMP DNA Amplification Preferred Specimen: Swab-E Alternate Specimen: Swab-Bacterial Culture Specimen Comment: Turn Around Time: 2 days Ref Range: Negative 0079-4 CPT Code: 87651 t(4;14) by FISH-TC Only A875-7 Alternate Name: T(4;14) BY FISH-TC ONLY Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367-TC (2) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: Prognostic for patients with Plasma Cell Myeloma. Commonly ordered through the Multiple Myeloma FISH panel (TC Only), P961-6. T3 Uptake, Serum (T3U) 0152-9 Alternate Name: T3 UPTAKE (T3U) Methodology: Electrochemiluminescene Immunoassay Preferred Specimen: 1 mL SST Tube CPT Code: 84479 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: 24.3-39.0 %,22.5-37.0 % T3, Total 0150-3 Alternate Name: T3 (THYRONINE), TOTAL Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 84480 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: 75-205 ng/dL,0.60-1.81 ng/dL,65-260 ng/dL,103-236 ng/dL,114-222 ng/dL,105-211 ng/dL,89-191 ng/dL,72-180 ng/dL,See Below ng/dL 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A52 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 TCR gamma by PCR 5031-0 Alternate Name: TCR-gamma, PCR Methodology: PCR Preferred Specimen: 2 mL Bone Marrow - Lavender Top CPT Code: 81342 (1) Alternate Specimen: 5 mL Peripheral Blood - Lavender Top,Tissue in RPMI,Peripheral Blood - Green Top,Formalin-fixed, Paraffin-embedded Tissue,Bone Marrow - Green Top,Slides,Shavings Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: Assess clonality in T-cells. Useful for assessment of T-cell lymphoma. Ref Range: See Report TEL/AML1: t(12;21) by FISH 5038-5 Alternate Name: TEL/AML1, t(12;21),FISH Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88368 (2) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition Storage Instruction: Refrigerate Turn Around Time: 5 days Clinical Indication: Useful for assessment of a subtype of B-lymphoblastic leukemia/lymphoma, usually in childhood. Ref Range: See Report Thyroid Stimulating Hormone (TSH) 0153-7 Alternate Name: TSH Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 84443 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: 0.064-4.570 uIU/mL,0.55-4.78 uIU/mL,0.246-4.849 uIU/mL,0.688-4.750 uIU/mL,0.782-4.730 uIU/mL,0.634-4.610 uIU/ mL,0.478-4.380 uIU/mL,0.178-4.530 uIU/mL,See Below uIU/mL Thyroxine (T4), Serum 0151-1 Alternate Name: THYROXINE(T4) Methodology: Electrochemiluminescene Immunoassay Preferred Specimen: 1 mL SST Tube CPT Code: 84436 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: 4.5-14.4 ug/dL,4.5-10.9 ug/dL,4.5-14.0 ug/dL,5.8-12.5 ug/dL,5.7-11.9 ug/dL,4.8-11.3 ug/dL,4.7-11.6 ug/dL,4.9-12.9 ug/dL,See Below ug/dL Trisomy 12 by FISH-TC Only A877-3 Alternate Name: TRISOMY 12 BY FISH-TC Methodology: FISH Preferred Specimen: 5 mL Peripheral Blood - Green Top CPT Code: 88367 (1) Alternate Specimen: 2 mL Bone Marrow - Green Top Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: Trisomy 12 by FISH is used for diagnostic and prognostic purposes in patients with CLL. Commonly ordered through the CLL FISH panel (TC Only), P962-4. A53 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Trisomy 8 By FISH-TC Only A870-8 Alternate Name: TRISOMY 8 BY FISH-TC Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88367-TC (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: Useful for assessment of primary myeloid disorders, including MDS. Commonly ordered through the MDS FISH panel (TC Only), P960-8. Tumor of Unknown Primary IHC Panel 5190-4 Alternate Name: TUMOR OF UNK.PRIM.ORIGIN Methodology: IHC Preferred Specimen: Formalin-fixed, Paraffin-embedded Tissue CPT Code: G0461 (1), G0462 (13) Alternate Specimen: Unstained Slide Specimen Comment: Turn Around Time: 1 days Clinical Indication: The tumor of unknown primary IHC panel is used to determine the primary tumor site. Number of IHC markers will vary based on each case. Ref Range: See Report UGT1A1 Mutation Analysis 5183-9 Alternate Name: UGT1A1 Methodology: PCR Preferred Specimen: 5 mL Lavender top- EDTA CPT Code: 81350 (1) Alternate Specimen: Peripheral Blood - Lavender Top,LIGHT GREEN LITHIUM HEPARIN,Green top Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 7 days Clinical Indication: UGT1A1 analysis detects enzyme deficiencies that lead to impaired metabolism of chemotherapy. Clinicians may titrate colorectal patients harboring UGT1A1 mutations for irinotecan. Ref Range: See Report Uric Acid, Urine, 24 Hours Alternate Name: URIC ACID,URINE 24 HR Preferred Specimen: 5 mL Urine Container - 24hr Alternate Specimen: Urine Cup 24 hour,Urine Tube 24 hour Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 2 days 0158-6 CPT Code: 84560 (1), 81050 (1) Urinalysis, Routine 0159-4 Alternate Name: URINALYSIS (UA) Preferred Specimen: 12 mL Urine Urinalysis Tube - Yellow CPT Code: 81001 (1) Alternate Specimen: Urine Cup,Urine Container - 24hr,Urine tube without preservative,Urine Cup 24 hour,Urine Tube 24 hour Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Urine Cytology- TC Only Alternate Name: CYTOPATHOLOGY URINE-TC (THINPREP Preferred Specimen: 50 mL Voided Urine - Urocyte Collection Kit Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 3 days Clinical Indication: To aid in the diagnosis of bladder cancer. 5218-3 CPT Code: 88112-TC (1) 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A54 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 Urine Cytopathology, Global Alternate Name: URINE CYTOPATHOLOGY Preferred Specimen: 50 mL ThinPrep Cytolyte Solution Specimen Comment: Turn Around Time: 3 days Clinical Indication: To aid in the diagnosis of bladder cancer. Ref Range: See Report 5254-8 CPT Code: 88112 (1) UroVysion- TC Only Alternate Name: UROVYSION-TC ONLY Methodology: FISH Preferred Specimen: 50 mL Voided Urine - Urocyte Collection Kit Specimen Comment: Please include specimen collection date on requisition. Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: Technical component for the diagnostic of bladder cancer. 5249-8 CPT Code: 88121-TC (1) Vitamin B12, Serum 0160-2 Alternate Name: VITAMIN B12 Methodology: Chemiluminescence Preferred Specimen: 1 mL SST Tube CPT Code: 82607 (1) Alternate Specimen: Aliquot Tube-Serum,Red Top,Microtainer - Pediatric SST,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 1 days Ref Range: 211-911 pg/mL Vitamin D, 25-Hydroxy, Serum 0286-5 Alternate Name: 25OH, VITAMIN D Methodology: Chemiluminescence Preferred Specimen: 2 mL SST Tube CPT Code: 82306 (1) Alternate Specimen: Red Top,Microtainer - Pediatric SST,Aliquot Tube-Serum,Microtainer - Pediatric Red Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 2 days Ref Range: 32.0-100.0 ng/mL Warfarin Sensitivity Alternate Name: WARFARIN PHARMACOGEN Methodology: PCR Preferred Specimen: 2 mL Lavender top- EDTA CPT Code: 81355 (1) Alternate Specimen: Microtainer - Pediatric Lavender Specimen Comment: Storage Instruction: Refrigerate Turn Around Time: 3 days Clinical Indication: Provides guidance to clinicians in warfarin dosing. This test includes VKOR and CYP. Ref Range: See Report A55 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. 6261-2 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 X/Y Bone Marrow Transplant Monitoring 5066-6 Alternate Name: BONE MARROW X/Y CHROM(FISH) Methodology: FISH Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88368 (2) Alternate Specimen: 5 mL Peripheral Blood - Green Top Specimen Comment: Please include specimen collection date on requisition Storage Instruction: Refrigerate Turn Around Time: 3-5 days Clinical Indication: For identification and monitoring of sex-mismatched bone marrow transplants. Ref Range: See Report ZAP-70 by Flow Cytometry 5409-8 Alternate Name: ZAP-70 PROFILE BY FLOW Methodology: Flow Cytometry Preferred Specimen: 2 mL Bone Marrow - Green Top CPT Code: 88184 (1), 88185 (3), 88187 (1) Alternate Specimen: 5 mL Peripheral Blood - Green Top,Peripheral Blood - Lavender Top,Bone Marrow - Lavender Top Specimen Comment: If submitting Peripheral Blood Lav, 5 ml is required. Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: ZAP-70 analysis is an independent CLL prognostic marker and surrogate marker for IgVH. Flow cytometry quantitates the level of ZAP-70 expression in CLL cells. Ref Range: See Report ZAP-70- TC Only 5110-2 Alternate Name: ZAP-70 PROFILE (TC ONLY) Methodology: Flow Cytometry Preferred Specimen: 5 mL Peripheral Blood - Green Top CPT Code: 88184 (1), 88185 (3) Alternate Specimen: 2 mL Bone Marrow - Green Top,Peripheral Blood - Lavender Top Specimen Comment: If submitting bone marrow place bone marrow into tube, label with patient's name. Send in bone marrow kit. Storage Instruction: Refrigerate Turn Around Time: 1 days Clinical Indication: ZAP-70 analysis is an independent CLL prognostic marker and surrogate marker for IgVH. Flow cytometry quantitates the antibody levels. 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. A56 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 A57 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 By Test Name Test Code Test Name Page A869-0 A868-2 A879-9 A872-4 A878-1 A874-0 A311-3 A876-5 A871-6 3283-9 5515-2 5516-0 5116-9 5181-3 5108-6 A703-1 A241-2 B236-1 B603-2 P260-3 0025-7 8860-9 5024-5 5034-4 5260-5 5261-3 5427-0 5025-2 5035-1 P261-1 5988-1 A881-5 5269-6 0041-4 0038-0 0042-2 5030-2 5032-8 5278-7 5273-8 5026-0 A873-2 5270-4 5271-2 B350-0 5028-6 B348-4 A880-7 5858-6 5265-4 0262-6 1754-1 5199-5 5202-7 5200-1 5211-8 -5/5q- by FISH- TC Only -7/7q- by FISH- TC Only 11q22.3 by FISH- TC Only 13q14 by FISH- TC Only 13q14.3 by FISH- TC Only 17p13 by FISH- TC Only 1p/19q by FISH 1q21 by FISH- TC Only 20q12 by FISH- TC Only Acute Hepatitis Panel for Medicare Acute Leukemia & Myeloid Disorders Analysis Acute Leukemia & Myeloid Disorders Analysis- TC Only Acute Leukemia/MDS IHC Panel Adenocarcinoma vs. Mesothelioma IHC Panel AE1/AE3- TC Only ALK by FISH ALK by FISH (FDA) ALK by FISH- TC Only ALK by IHC - TC Only ALL Prognosis Panel by FISH Alpha Fetoprotein, Tumor Marker (AFP) AML - CEBPA Mutational Analysis AML - M2 (AML/ETO) (RUNX1/RUNX1T1) by FISH AML - M2 (AML/ETO) (RUNX1/RUNX1T1) by RT-PCR AML - M3 (PML/RARA) by FISH AML - M3 (PML/RARA) by RT-PCR AML - M4 & M5 by FISH AML - M4Eo inv(16) by FISH AML - M4Eo inv(16) by PCR AML Diagnostic Panel by FISH AML Prognostic Panel: FLT3 & NPM1 AML-M3(PML/RARA) by FISH- TC Only AML: NPM1 Mutation Analysis Anti-Thyroglobulin Antibody (ATA) Antinuclear Antibody (ANA) Antistreptolysin O (ASO) Titer Automated UroVysion By FISH B-Cell, IGH by FISH B-Cell, IGH by PCR BCL1, BCL2, BCL6 (FISH Panel) BCL1/IGH (CCND1/IGH) by FISH BCL1/IGH (CCND1/IGH) by FISH-TC Only BCL2/IGH by FISH BCL2/IGH by PCR BCL2/IGH: t(14;18) by FISH- TC Only BCL6 by FISH BCL6: 3q27 by FISH- TC Only BCR/ABL by FISH-TC Only BCR/ABL Quantification by RT-PCR BCR/ABL: t(9;22) by FISH Beta-2-Microglobulin, Serum Beta-2-Microglobulin, Urine, Random Bone Marrow Morphology Bone Marrow Morphology - Clot Only Bone Marrow Morphology - Core Only Bone Marrow Morphology - Smears A1 A1 A1 A1 A2 A2 A2 A2 A2 A3 A3 A3 A3 A3 A4 A4 A4 A4 A5 A5 A5 A5 A5 A6 A6 A6 A6 A6 A7 A7 A7 A7 A7 A8 A8 A8 A8 A8 A9 A9 A9 A9 A9 A10 A10 A10 A10 A10 A11 A11 A11 A11 A11 A12 A12 A12 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. B1 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 By Test Name B2 Test Code Test Name Page 5207-6 5285-2 5893-3 A566-2 5118-5 5176-3 A952-4 5170-6 3320-9 0536-3 2130-3 0535-5 0823-5 0359-0 0055-4 0053-9 2665-8 5250-6 6237-2 0021-6 5434-6 5404-9 5280-3 P962-4 6290-1 P264-5 B365-8 0532-2 0533-0 3427-2 5256-3 5324-9 5253-0 0064-6 0900-1 0072-9 0341-8 0080-2 0082-8 5847-9 5296-9 5287-8 0400-2 0461-4 5555-8 5575-6 6285-1 0234-5 0580-1 0582-7 0583-5 5295-1 A675-1 0002-6 0404-4 B565-3 Bone Marrow Slide Consult Bone Marrow Smear Interpretation BRAF V600E BRAF V600E (FDA) Breast Carcinoma, Marrow, IHC Micromets Breast Carcinoma, rule out Microinvasion Breast Carcinoma, rule out Microinvasion- TC Only Breast Carcinoma/Lymph Nodes/MM Metastasis C-Reactive Protein (hs-CRP), High Sensitivity CA 125, Serum CA 15-3, Serum CA 19-9, Serum CA 27.29, Serum Calcium, Urine, 24 Hours Carcinoembryonic Antigen (CEA) CBC w/Diff, Platelet Ct. Chlamydia trachomatis (CT), Urine, Probetec Chromosome Analysis Circulating Tumor Cells (CTC) Citrate, 24Hr. Urine CK-903 for Prostate Cancer CK-903- TC Only CLL FISH Panel CLL FISH Panel- TC Only CML: ABL Kinase Mutation Analysis Colon DNA Mismatch Repair Reflex Colon Reflex Dx Complement C3, Serum Complement C4, Serum Comprehensive Metabolic Panel (CMP) Comprehensive Slide Consult Comprehensive Urine Pathology Comprehensive Urine Pathology- TC Only Coombs Test, Direct Cortisol, Serum, Random Creatinine Clearance, Urine, 24 Hours Culture, Blood Culture, Urine Culture, Wound, Aerobic Only CYP2C19 Pharmacogenomic (Plavix) CYP2D6 (NY Only): Tamoxifen Resistance CYP2D6: Tamoxifen Resistance (non-NY only) Cytomegalovirus (CMV) Antibody, IgG Cytomegalovirus (CMV) Antibody, IgM DNA Ploidy for Molar Pregnancy DNA Ploidy/S-Phase by Flow Cytometry DPD 5-FU Genotype EBV Capsid Ab, IgG EBV Capsid Ab, IgM EBV, Early Antigen Ab EBV, Nuclear Antigen Ab, IgG EGFR by PCR EGFR by PCR if neg. reflex to ALK Electrolytes, Serum Electrophoresis, Urine Protein (UPEP) EML4-ALK by IHC A12 A12 A13 A13 A13 A13 A13 A14 A14 A14 A14 A14 A15 A15 A15 A15 A15 A16 A16 A16 A16 A16 A17 A17 A17 A17 A17 A18 A18 A18 A18 A18 A19 A19 A19 A19 A19 A20 A20 A20 A20 A20 A21 A21 A21 A21 A21 A22 A22 A22 A22 A22 A23 A23 A23 A23 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 By Test Name Test Code Test Name Page 5198-7 5160-7 5433-8 5163-1 5131-8 5162-3 5408-0 5161-5 5406-4 A277-6 5127-6 A278-4 5407-2 A951-6 5129-2 A276-8 5425-4 A300-6 0183-4 0516-5 0562-9 5727-3 5726-5 0088-5 5178-9 0090-1 0092-7 3893-5 5306-6 5194-6 5175-5 2666-6 0514-0 1766-5 1765-7 7736-2 0102-4 0216-2 3422-3 5193-8 5171-4 5262-1 A427-7 A428-5 5428-8 A972-2 5405-6 5259-7 3420-7 0360-8 0375-6 5101-1 8714-8 8689-2 8696-7 3412-4 ER / PR - w/Interpretation ER / PR / DNA / Ki-67 - w/Interpretation ER / PR / Ki-67 / HER2- TC Only ER / PR / Ki-67/ HER2 - w/Interpretation ER / PR / Ki-67 / HER2 (Tech Only), plus DNA (Global) ER / PR / DNA / Ki-67 / HER2 - w/Interpretation ER / PR / DNA / Ki-67 / HER2 - Reflex to HER2 by FISH ER / PR / HER2 - w/Interpretation ER / PR / HER2 - Reflex to HER2 by FISH ER / PR / HER2 FISH- TC Only ER / PR / HER2- TC Only ER / PR / Ki-67 / p53 / HER2 FISH- TC Only ER / PR / Ki-67 / HER2 - Reflex to HER2 by FISH ER / PR / Ki-67 / HER2 / p53, TC Only ER / PR / Ki-67- TC Only, plus DNA- Global ER / PR / Ki67 / p53 / HER2 FISH -TC Only plus DNA- Global ER / PR- TC Only ERCC1 Erythropoietin, Serum Estradiol, Serum Estrogen, Total, Serum Factor V (R2) Polymorphism Factor V Mutation (Leiden) Ferritin, Serum FLT3 Mutation Analysis Folate, Serum Follicle Stimulating Hormone (FSH) Free Kappa & Lambda Light Chain (serum) GenArray Molecular Karyotyping Germ Cell Tumor IHC Panel GIST Profile Gonorrhea (GC), Urine, Probetec Haptoglobin, Serum Helicobacter pylori, IgA Helicobacter pylori, IgG Helicobacter pylori, IgM Hemoglobin A1C Hemoglobin Fractionation, HPLC Hepatic Function Panel Hepatocellular vs. Cholangiocarcinoma vs. Metastasis IHC Panel HER2 by IHC HER2 by FISH HER2 by FISH - Gastric/GEJ HER2 by FISH for Gastric/GEJ- TC Only HER2 by IHC - Reflex +2 to HER2 by FISH HER2 by IHC in Gastric/Gastroesophageal Carcinoma HER2 by IHC- TC Only HER2 FISH- TC Only Hereditary Hemochromotosis (HFE): C282Y, H63D, S65C HIV-1/HIV-2 Antibody Screen HLA-B27 Hodgkin Lymphoma IHC Panel HPV High by ISH HPV High by ISH- TC Only HPV High/Low by ISH- TC Only HPV High/Low Risk by ISH A23 A24 A24 A24 A24 A25 A25 A25 A25 A25 A26 A26 A26 A26 A26 A27 A27 A27 A27 A27 A28 A28 A28 A28 A28 A29 A29 A29 A29 A29 A30 A30 A30 A30 A30 A31 A31 A31 A31 A31 A32 A32 A32 A32 A32 A33 A33 A33 A33 A33 A34 A34 A34 A34 A34 A35 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. B3 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 By Test Name B4 Test Code Test Name Page 1201-3 5080-7 5223-3 0413-5 1644-4 0520-7 0250-1 5307-4 5157-3 5152-4 A346-9 5179-7 A344-4 5288-6 5891-7 0117-2 0009-1 2194-9 B367-4 P263-7 B369-0 A130-7 B368-2 0342-6 0568-6 5535-0 5536-8 B366-6 5281-1 P960-8 B335-1 B336-9 A612-4 5124-3 5126-8 3371-2 5155-7 A943-3 A944-1 A313-9 5272-0 5765-3 5764-6 5282-9 P961-6 5579-8 5027-8 B349-2 B338-5 B271-8 5195-3 6274-5 5500-4 A500-1 Q429-3 A635-5 Human Chorionic Gonadotropin (HCG), Quantitative, Tumor Marker IgH/TCR-GAMMA by PCR IgVH Mutation Analysis Immunofixation, Serum Immunofixation, Urine, Random Immunoglobulins, Serum Iron + TIBC JAK2 Exon 12 JAK2 V617F Ki-67 by IHC Ki-67 by IHC- TC Only KIT (D816V) by PCR KIT/PDGFRA for GIST by PCR KRAS KRAS if Negative Reflex to BRAF Lactate Dehydrogenase (LDH), Serum Lipid Panel Low-density lipoprotein (LDL) Direct Lung Adeno Reflex Dx Lung Adeno Reflex Panel: EGFR --> KRAS--> ALK Lung Adenocarcinoma Targeted Therapy Profile Lung Histology IHC Panel Lung Profile: KRAS, EGFR, EML4-ALK, ROS1 Luteinizing Hormone (LH) Lyme Disease Antibody, Serum Lymphoproliferative Disorder Analysis Lymphoproliferative Disorder Analysis (Technical Only) Lynch Syndrome Reflex Screening MDS FISH Panel MDS FISH Panel- TC Only MET by FISH MET by FISH - TC Only MET by IHC Metastatic Carcinoma (Breast, Colon) - Lymph Node Metastatic Melanoma - Lymph Node Microsatellite Instability (MSI-H) by PCR Minimal Residual Disease for CLL/SLL Mismatch Repair Protein (MMR) for Lynch Syndrome by IHC Mismatch Repair Protein (MMR) for Lynch Syndrome by IHC- TC Only MLH1 Promoter Hypermethylation MPL515 MTHFR A1298C MTHFR C677T Gene Mutation Multiple Myeloma FISH Panel Multiple Myeloma FISH Panel-TC Only Multiple Myeloma IHC Panel MYC/IGH by FISH MYC/IGH: t(8;14) by FISH- TC Only Myeloid & Lymphoid Analysis (Short Panel) - TC Only Myeloid and Lymphoid Short Panel Neuroendocrine Neoplasm IHC Panel Non-Automated UroVysion OneCheck Hematopathology OneCheck Plus GenArray OnkoMatch + for Lung, if ALK negative reflex to ROS1 OnkoMatch Tumor Genotyping A35 A35 A35 A35 A36 A36 A36 A36 A36 A37 A37 A37 A37 A37 A38 A38 A38 A38 A38 A39 A39 A39 A39 A39 A40 A40 A40 A40 A41 A41 A41 A41 A41 A42 A42 A42 A42 A42 A43 A43 A43 A43 A43 A44 A44 A44 A44 A45 A45 A45 A45 A45 A46 A46 A46 A46 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 By Test Name Test Code Test Name Page A642-1 5153-2 A347-7 5564-0 5106-0 5111-0 A430-1 5182-1 5219-1 0411-9 5573-1 5574-9 5185-4 5122-7 0190-9 2088-3 5097-1 5104-5 0085-1 5795-0 5103-7 0141-2 0796-3 B334-4 0086-9 5177-1 5191-2 0079-4 A875-7 0152-9 0150-3 5031-0 5038-5 0153-7 0151-1 A877-3 A870-8 5190-4 5183-9 0158-6 0159-4 5218-3 5254-8 5249-8 0160-2 0286-5 6261-2 5066-6 5409-8 5110-2 OnkoMatch Tumor Genotyping + for Lung p53 by IHC p53 by IHC- TC Only Paroxysmal Nocturnal Hemoglobinuria (PNH) Test Pathology Peripheral Smear Review Pathology Slide Consultation PDGFR alpha PDGFR alpha/FIP1L1 by FISH PDGFRbeta/TEL Phosphates, Urine, 24 Hours Plasma Cell Analysis Plasma Cell Analysis - TC Only PNH- TC Only Prostate Cancer/ Lymph Nodes Prostate Specific Antigen (PSA) Prostate Specific Antigen (PSA), Free and Total, Serum Prostate Triple Stain Prostate Triple Stain- TC Only Protein Electrophoresis, Serum (SPEP) Prothrombin G20210A Mutation Reactive Hyperplasia vs. Lymphoma (NHL) IHC Panel Reticulocyte Count Rheumatoid Arthritis (RA) Factor ROS1 by FISH Sedimentation Rate, Erythrocyte (ESR) Small Round Cell Tumor IHC Panel Spindle Cell Neoplasm IHC Panel Strep Screen, Group A, Beta-Hemolytic t(4;14) by FISH-TC Only T3 Uptake, Serum (T3U) T3, Total TCR gamma by PCR TEL/AML1: t(12;21) by FISH Thyroid Stimulating Hormone (TSH) Thyroxine (T4), Serum Trisomy 12 by FISH-TC Only Trisomy 8 By FISH-TC Only Tumor of Unknown Primary IHC Panel UGT1A1 Mutation Analysis Uric Acid, Urine, 24 Hours Urinalysis, Routine Urine Cytology- TC Only Urine Cytopathology, Global UroVysion- TC Only Vitamin B12, Serum Vitamin D, 25-Hydroxy, Serum Warfarin Sensitivity X/Y Bone Marrow Transplant Monitoring ZAP-70 by Flow Cytometry ZAP-70- TC Only A46 A47 A47 A47 A47 A47 A48 A48 A48 A48 A48 A49 A49 A49 A49 A49 A50 A50 A50 A50 A50 A51 A51 A51 A51 A51 A52 A52 A52 A52 A52 A53 A53 A53 A53 A53 A54 A54 A54 A54 A54 A54 A55 A55 A55 A55 A55 A56 A56 A56 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. B5 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 By Test Code B6 Test Code Test Name Page 0002-6 0009-1 0021-6 0025-7 0038-0 0041-4 0042-2 0053-9 0055-4 0064-6 0072-9 0079-4 0080-2 0082-8 0085-1 0086-9 0088-5 0090-1 0092-7 0102-4 0117-2 0141-2 0150-3 0151-1 0152-9 0153-7 0158-6 0159-4 0160-2 0183-4 0190-9 0216-2 0234-5 0250-1 0262-6 0286-5 0341-8 0342-6 0359-0 0360-8 0375-6 0400-2 0404-4 0411-9 0413-5 0461-4 0514-0 0516-5 0520-7 0532-2 0533-0 0535-5 0536-3 0562-9 0568-6 0580-1 Electrolytes, Serum Lipid Panel Citrate, 24Hr. Urine Alpha Fetoprotein, Tumor Marker (AFP) Antinuclear Antibody (ANA) Anti-Thyroglobulin Antibody (ATA) Antistreptolysin O (ASO) Titer CBC w/Diff, Platelet Ct. Carcinoembryonic Antigen (CEA) Coombs Test, Direct Creatinine Clearance, Urine, 24 Hours Strep Screen, Group A, Beta-Hemolytic Culture, Urine Culture, Wound, Aerobic Only Protein Electrophoresis, Serum (SPEP) Sedimentation Rate, Erythrocyte (ESR) Ferritin, Serum Folate, Serum Follicle Stimulating Hormone (FSH) Hemoglobin A1C Lactate Dehydrogenase (LDH), Serum Reticulocyte Count T3, Total Thyroxine (T4), Serum T3 Uptake, Serum (T3U) Thyroid Stimulating Hormone (TSH) Uric Acid, Urine, 24 Hours Urinalysis, Routine Vitamin B12, Serum Erythropoietin, Serum Prostate Specific Antigen (PSA) Hemoglobin Fractionation, HPLC EBV Capsid Ab, IgG Iron + TIBC Beta-2-Microglobulin, Serum Vitamin D, 25-Hydroxy, Serum Culture, Blood Luteinizing Hormone (LH) Calcium, Urine, 24 Hours HIV-1/HIV-2 Antibody Screen HLA-B27 Cytomegalovirus (CMV) Antibody, IgG Electrophoresis, Urine Protein (UPEP) Phosphates, Urine, 24 Hours Immunofixation, Serum Cytomegalovirus (CMV) Antibody, IgM Haptoglobin, Serum Estradiol, Serum Immunoglobulins, Serum Complement C3, Serum Complement C4, Serum CA 19-9, Serum CA 125, Serum Estrogen, Total, Serum Lyme Disease Antibody, Serum EBV Capsid Ab, IgM A23 A38 A16 A5 A8 A8 A8 A15 A15 A19 A19 A52 A20 A20 A50 A51 A28 A29 A29 A31 A38 A51 A52 A53 A52 A53 A54 A54 A55 A27 A49 A31 A22 A36 A11 A55 A19 A39 A15 A33 A34 A21 A23 A48 A35 A21 A30 A27 A36 A18 A18 A14 A14 A28 A40 A22 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 By Test Code Test Code Test Name Page 0582-7 0583-5 0796-3 0823-5 0900-1 1201-3 1644-4 1754-1 1765-7 1766-5 2088-3 2130-3 2194-9 2665-8 2666-6 3283-9 3320-9 3371-2 3412-4 3420-7 3422-3 3427-2 3893-5 5024-5 5025-2 5026-0 5027-8 5028-6 5030-2 5031-0 5032-8 5034-4 5035-1 5038-5 5066-6 5080-7 5097-1 5101-1 5103-7 5104-5 5106-0 5108-6 5110-2 5111-0 5116-9 5118-5 5122-7 5124-3 5126-8 5127-6 5129-2 5131-8 5152-4 5153-2 5155-7 5157-3 EBV, Early Antigen Ab EBV, Nuclear Antigen Ab, IgG Rheumatoid Arthritis (RA) Factor CA 27.29, Serum Cortisol, Serum, Random Human Chorionic Gonadotropin (HCG), Quantitative, Tumor Marker Immunofixation, Urine, Random Beta-2-Microglobulin, Urine, Random Helicobacter pylori, IgG Helicobacter pylori, IgA Prostate Specific Antigen (PSA), Free and Total, Serum CA 15-3, Serum Low-density lipoprotein (LDL) Direct Chlamydia trachomatis (CT), Urine, Probetec Gonorrhea (GC), Urine, Probetec Acute Hepatitis Panel for Medicare C-Reactive Protein (hs-CRP), High Sensitivity Microsatellite Instability (MSI-H) by PCR HPV High/Low Risk by ISH Hereditary Hemochromotosis (HFE): C282Y, H63D, S65C Hepatic Function Panel Comprehensive Metabolic Panel (CMP) Free Kappa & Lambda Light Chain (serum) AML - M2 (AML/ETO) (RUNX1/RUNX1T1) by FISH AML - M4Eo inv(16) by FISH BCL1/IGH (CCND1/IGH) by FISH MYC/IGH by FISH BCL6 by FISH Automated UroVysion By FISH TCR gamma by PCR B-Cell, IGH by FISH AML - M2 (AML/ETO) (RUNX1/RUNX1T1) by RT-PCR AML - M4Eo inv(16) by PCR TEL/AML1: t(12;21) by FISH X/Y Bone Marrow Transplant Monitoring IgH/TCR-GAMMA by PCR Prostate Triple Stain Hodgkin Lymphoma IHC Panel Reactive Hyperplasia vs. Lymphoma (NHL) IHC Panel Prostate Triple Stain- TC Only Pathology Peripheral Smear Review AE1/AE3- TC Only ZAP-70- TC Only Pathology Slide Consultation Acute Leukemia/MDS IHC Panel Breast Carcinoma, Marrow, IHC Micromets Prostate Cancer/ Lymph Nodes Metastatic Carcinoma (Breast, Colon) - Lymph Node Metastatic Melanoma - Lymph Node ER / PR / HER2- TC Only ER / PR / Ki-67- TC Only, plus DNA- Global ER / PR / Ki-67 / HER2 (Tech Only), plus DNA (Global) Ki-67 by IHC p53 by IHC Minimal Residual Disease for CLL/SLL JAK2 V617F A22 A22 A51 A15 A19 A35 A36 A11 A30 A30 A49 A14 A38 A15 A30 A3 A14 A42 A35 A33 A31 A18 A29 A5 A6 A9 A44 A10 A8 A53 A8 A6 A7 A53 A56 A35 A50 A34 A50 A50 A47 A4 A56 A47 A3 A13 A49 A42 A42 A26 A26 A24 A37 A47 A42 A36 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. B7 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 By Test Code B8 Test Code Test Name Page 5160-7 5161-5 5162-3 5163-1 5170-6 5171-4 5175-5 5176-3 5177-1 5178-9 5179-7 5181-3 5182-1 5183-9 5185-4 5190-4 5191-2 5193-8 5194-6 5195-3 5198-7 5199-5 5200-1 5202-7 5207-6 5211-8 5218-3 5219-1 5223-3 5249-8 5250-6 5253-0 5254-8 5256-3 5259-7 5260-5 5261-3 5262-1 5265-4 5269-6 5270-4 5271-2 5272-0 5273-8 5278-7 5280-3 5281-1 5282-9 5285-2 5287-8 5288-6 5295-1 5296-9 5306-6 5307-4 5324-9 ER / PR / DNA / Ki-67 - w/Interpretation ER / PR / HER2 - w/Interpretation ER / PR / DNA / Ki-67 / HER2 - w/Interpretation ER / PR / Ki-67/ HER2 - w/Interpretation Breast Carcinoma/Lymph Nodes/MM Metastasis HER2 by IHC GIST Profile Breast Carcinoma, rule out Microinvasion Small Round Cell Tumor IHC Panel FLT3 Mutation Analysis KIT (D816V) by PCR Adenocarcinoma vs. Mesothelioma IHC Panel PDGFR alpha/FIP1L1 by FISH UGT1A1 Mutation Analysis PNH- TC Only Tumor of Unknown Primary IHC Panel Spindle Cell Neoplasm IHC Panel Hepatocellular vs. Cholangiocarcinoma vs. Metastasis IHC Panel Germ Cell Tumor IHC Panel Neuroendocrine Neoplasm IHC Panel ER / PR - w/Interpretation Bone Marrow Morphology Bone Marrow Morphology - Core Only Bone Marrow Morphology - Clot Only Bone Marrow Slide Consult Bone Marrow Morphology - Smears Urine Cytology- TC Only PDGFRbeta/TEL IgVH Mutation Analysis UroVysion- TC Only Chromosome Analysis Comprehensive Urine Pathology- TC Only Urine Cytopathology, Global Comprehensive Slide Consult HER2 FISH- TC Only AML - M3 (PML/RARA) by FISH AML - M3 (PML/RARA) by RT-PCR HER2 by FISH BCR/ABL: t(9;22) by FISH AML: NPM1 Mutation Analysis BCL2/IGH by FISH BCL2/IGH by PCR MPL515 BCL1, BCL2, BCL6 (FISH Panel) B-Cell, IGH by PCR CLL FISH Panel MDS FISH Panel Multiple Myeloma FISH Panel Bone Marrow Smear Interpretation CYP2D6: Tamoxifen Resistance (non-NY only) KRAS EGFR by PCR CYP2D6 (NY Only): Tamoxifen Resistance GenArray Molecular Karyotyping JAK2 Exon 12 Comprehensive Urine Pathology A24 A25 A25 A24 A14 A32 A30 A13 A51 A28 A37 A3 A48 A54 A49 A54 A52 A31 A29 A45 A23 A11 A12 A12 A12 A12 A54 A48 A35 A55 A16 A19 A55 A18 A33 A6 A6 A32 A11 A7 A9 A10 A43 A9 A9 A17 A41 A44 A12 A20 A37 A22 A20 A29 A36 A18 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. T E S T L I S T I N G DIRECTORY OF SERVICES 2014 By Test Code Test Code Test Name Page 5404-9 5405-6 5406-4 5407-2 5408-0 5409-8 5425-4 5427-0 5428-8 5433-8 5434-6 5500-4 5515-2 5516-0 5535-0 5536-8 5555-8 5564-0 5573-1 5574-9 5575-6 5579-8 5726-5 5727-3 5764-6 5765-3 5795-0 5847-9 5858-6 5891-7 5893-3 5988-1 6237-2 6261-2 6274-5 6285-1 6290-1 7736-2 8689-2 8696-7 8714-8 8860-9 A130-7 A241-2 A276-8 A277-6 A278-4 A300-6 A311-3 A313-9 A344-4 A346-9 A347-7 A427-7 A428-5 A430-1 CK-903- TC Only HER2 by IHC- TC Only ER / PR / HER2 - Reflex to HER2 by FISH ER / PR / Ki-67 / HER2 - Reflex to HER2 by FISH ER / PR / DNA / Ki-67 / HER2 - Reflex to HER2 by FISH ZAP-70 by Flow Cytometry ER / PR- TC Only AML - M4 & M5 by FISH HER2 by IHC - Reflex +2 to HER2 by FISH ER / PR / Ki-67 / HER2- TC Only CK-903 for Prostate Cancer OneCheck Hematopathology Acute Leukemia & Myeloid Disorders Analysis Acute Leukemia & Myeloid Disorders Analysis- TC Only Lymphoproliferative Disorder Analysis Lymphoproliferative Disorder Analysis (Technical Only) DNA Ploidy for Molar Pregnancy Paroxysmal Nocturnal Hemoglobinuria (PNH) Test Plasma Cell Analysis Plasma Cell Analysis - TC Only DNA Ploidy/S-Phase by Flow Cytometry Multiple Myeloma IHC Panel Factor V Mutation (Leiden) Factor V (R2) Polymorphism MTHFR C677T Gene Mutation MTHFR A1298C Prothrombin G20210A Mutation CYP2C19 Pharmacogenomic (Plavix) BCR/ABL Quantification by RT-PCR KRAS if Negative Reflex to BRAF BRAF V600E AML Prognostic Panel: FLT3 & NPM1 Circulating Tumor Cells (CTC) Warfarin Sensitivity Non-Automated UroVysion DPD 5-FU Genotype CML: ABL Kinase Mutation Analysis Helicobacter pylori, IgM HPV High by ISH- TC Only HPV High/Low by ISH- TC Only HPV High by ISH AML - CEBPA Mutational Analysis Lung Histology IHC Panel ALK by FISH (FDA) ER / PR / Ki67 / p53 / HER2 FISH -TC Only plus DNA- Global ER / PR / HER2 FISH- TC Only ER / PR / Ki-67 / p53 / HER2 FISH- TC Only ERCC1 1p/19q by FISH MLH1 Promoter Hypermethylation KIT/PDGFRA for GIST by PCR Ki-67 by IHC- TC Only p53 by IHC- TC Only HER2 by FISH - Gastric/GEJ HER2 by FISH for Gastric/GEJ- TC Only PDGFR alpha A16 A33 A25 A26 A25 A56 A27 A6 A32 A24 A16 A46 A3 A3 A40 A40 A21 A47 A48 A49 A21 A44 A28 A28 A43 A43 A50 A20 A11 A38 A13 A7 A16 A55 A45 A21 A17 A31 A34 A34 A34 A5 A39 A4 A27 A25 A26 A27 A2 A43 A37 A37 A47 A32 A32 A48 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. B9 T E S T L I S T I N G DIRECTORY OF SERVICES 2014 By Test Code Test Code Test Name Page A500-1 A566-2 A612-4 A635-5 A642-1 A675-1 A703-1 A868-2 A869-0 A870-8 A871-6 A872-4 A873-2 A874-0 A875-7 A876-5 A877-3 A878-1 A879-9 A880-7 A881-5 A943-3 A944-1 A951-6 A952-4 A972-2 B236-1 B271-8 B334-4 B335-1 B336-9 B338-5 B348-4 B349-2 B350-0 B365-8 B366-6 B367-4 B368-2 B369-0 B565-3 B603-2 P260-3 P261-1 P263-7 P264-5 P960-8 P961-6 P962-4 Q429-3 OneCheck Plus GenArray BRAF V600E (FDA) MET by IHC OnkoMatch Tumor Genotyping OnkoMatch Tumor Genotyping + for Lung EGFR by PCR if neg. reflex to ALK ALK by FISH -7/7q- by FISH- TC Only -5/5q- by FISH- TC Only Trisomy 8 By FISH-TC Only 20q12 by FISH- TC Only 13q14 by FISH- TC Only BCL1/IGH (CCND1/IGH) by FISH-TC Only 17p13 by FISH- TC Only t(4;14) by FISH-TC Only 1q21 by FISH- TC Only Trisomy 12 by FISH-TC Only 13q14.3 by FISH- TC Only 11q22.3 by FISH- TC Only BCR/ABL by FISH-TC Only AML-M3(PML/RARA) by FISH- TC Only Mismatch Repair Protein (MMR) for Lynch Syndrome by IHC Mismatch Repair Protein (MMR) for Lynch Syndrome by IHC- TC Only ER / PR / Ki-67 / HER2 / p53, TC Only Breast Carcinoma, rule out Microinvasion- TC Only HER2 by IHC in Gastric/Gastroesophageal Carcinoma ALK by FISH- TC Only Myeloid and Lymphoid Short Panel ROS1 by FISH MET by FISH MET by FISH - TC Only Myeloid & Lymphoid Analysis (Short Panel) - TC Only BCL6: 3q27 by FISH- TC Only MYC/IGH: t(8;14) by FISH- TC Only BCL2/IGH: t(14;18) by FISH- TC Only Colon Reflex Dx Lynch Syndrome Reflex Screening Lung Adeno Reflex Dx Lung Profile: KRAS, EGFR, EML4-ALK, ROS1 Lung Adenocarcinoma Targeted Therapy Profile EML4-ALK by IHC ALK by IHC - TC Only ALL Prognosis Panel by FISH AML Diagnostic Panel by FISH Lung Adeno Reflex Panel: EGFR --> KRAS--> ALK Colon DNA Mismatch Repair Reflex MDS FISH Panel- TC Only Multiple Myeloma FISH Panel-TC Only CLL FISH Panel- TC Only OnkoMatch + for Lung, if ALK negative reflex to ROS1 A46 A13 A41 A46 A46 A23 A4 A1 A1 A54 A2 A1 A9 A2 A52 A2 A53 A2 A1 A10 A7 A42 A43 A26 A13 A33 A4 A45 A51 A41 A41 A45 A10 A45 A10 A17 A40 A38 A39 A39 A23 A5 A5 A7 A39 A17 A41 A44 A17 A46 B10 481 Edward H. Ross Drive Elmwood Park, New Jersey 07407 | (800) 627-1479 | FAX (201) 791-1941 | www.genpath.com GenPath is a business unit of BioReference Laboratories. 481 Edward H. Ross Drive, Elmwood Park, NJ 07407 Tel: 800-627-1479 | Fax: 201-791-8760 | www.genpath.com