Tumor Profiling Requisition

Tumor Profiling Requisition
Fax completed requisition with a copy of the pathology report, clinical history and insurance information to (866) 479-4925.
TREATING PHYSICIAN INFORMATION
PATIENT INFORMATION
NameNPI#
Last Name
Office/Hospital Name Address
Street Address
Apt#
City
StateZip
City
Zip
Phone #
Fax #
Patient Phone #
Patient Work Phone #
Patient MR #
DOB
Contact Name
First Name
ADDITIONAL PHYSICIAN (If different than above)
PATHOLOGY INFORMATION
NameFacility
Pathologist/Pathology Services
Address
City
Phone #
Fax #
State
State
MI
Gender
Male
Female
Hospital CityState
Zip
PhoneFax
Zip
BILLING INFORMATION (Attach the front and back of PRIMARY and SECONDARY insurance cards. Patient insurance/payment is REQUIRED to begin testing.)
ICD-9 Code(s) (Please provide as many “symptomatic diagnosis” codes as applicable):
Bill:
Self Pay
Insurance
Indigent Care
website for eligibility Medicare (Visit
requirements.)
Other: ___________________
POLICY #
GROUP #
INSURED NAME
RELATIONSHIP
TO PATIENT
INSURED DOB
Primary Insurance:
Secondary Insurance:
Self
Spouse
Child
Other ______________________
Self
Spouse
Child
Other ______________________
SPECIMEN INFORMATION (Include a copy of the pathology report)
Specimen Collection Location
Office/Clinic
Ambulatory Center
Hospital Outpatient
Hospital Inpatient – Date of Discharge ________________
Primary Tumor Site
Date & Time of Collection (Formalin Vials)
/
/
AM
PM
Specimen Collection Location Name
Specimen Site
Duration of Fixation (FFPE Blocks)
Tissue Type(s):
FFPE Block
Specimen/Block ID#(s)
Formalin Fixative*
Unstained Slides
*Submission of these samples constitutes
a pathology consult by Caris (CPT 88305).
CARIS MOLECULAR INTELLIGENCE™ TUMOR PROFILING OPTIONS (Choice Required)
Select a service or individual assay(s) to be performed from the list below. See reverse side for profile details. While every attempt is made to keep this requisition current,
the definitive list of assays included in each profile and list of available biomarkers can be found online at www.CarisMolecularIntelligence.com/profilemenu.
SERVICES (See reverse for further details)
INDIVIDUAL ASSAY(S)
MI Profile™
Multi-platform, solid tumor biomarker analysis for therapeutic decision
support and clinical trials matching (see reverse for profile details)
Helpful when:
• treating aggressive, rare or refractory cancers
• looking for clinical trial opportunities
Next-Generation Sequencing Cancer Service – Only
Solid tumor, 46-gene sequencing profile (see reverse for biomarker list)
The biomarkers included in MI Profile™ and Next-Generation Sequencing Cancer Service may change
from time-to-time. As a result, the listing on this printed requisition may occasionally become
outdated for a short period of time. Before ordering testing services, please refer to the website,
www.CarisMolecularIntelligence.com/profilemenu, to view the most up-to-date listing of biomarkers
that will be performed.
IHC
AR
cMET
EGFR
ER
ERCC1
H3K36me3
(kidney only)
HER2
MGMT
PBRM1
(kidney only)
PD-1
1
2
PD-L1
Pgp
PR
PTEN
RRM1
SPARCm
SPARCp
TLE3
TOPO1
TOP2A
TS
TUBB3
Mismatch Repair1:
(includes 4 IHCs below)
performed for CRC and endometrial carcinomas
Assay may be performed by an external reference
laboratory.
MLH1
MSH2
MSH6
PMS2
FISH or CISH
1p19q (glioma only)
ALK
cMET
EGFR
MDM2
HER2
ROS1
TOP2A
Mutational Analysis
BRAF2 (cobas® PCR)
EGFRvIII (Fragment Analysis)
IDH2 (SangerSeq)
MGMT Methylation
Analysis (PyroSeq)
MSI1 (Fragment Analysis)
Individual Next-Generation
Sequencing Genes
(List the genes to be performed. See reverse for gene list):
___________ ___________
___________ ___________
___________ ___________
ADDITIONAL SERVICES
Pathology Consult – Perform a pathology review/consult (CPT: 88305*, or 88321, or 88323) on the specimen submitted.
Yes
Clinical Trials Connector™ – The MI Profile™ report includes information on relevant clinical trials. To decline the service, check box.
Do Not Provide Information on Clinical Trials
SPECIAL INSTRUCTIONS
Physician Initials
Notice: This requisition constitutes an order for services. I certify (a) that the services are medically indicated
Physician or Practitioner Signature
Print Name
Date
and necessary and will assist me in treating my patient, (b) that I maintain and will make available patient
medical records documenting the foregoing, and (c) I have supplied information to the patient regarding
testing and if required by law, the patient has given consent for testing to be performed.
PLEASE SEE THE REVERSE FOR CMS BILLING AND PATIENT CONSENT REQUIREMENTS, PROFILE DESCRIPTIONS AND OPTIMAL SPECIMEN REQUIREMENTS.
4610 South 44th Place, Suite 100 / Phoenix, Arizona 85040 / (888) 979-8669 / Fax: (866) 479-4925 / CLIA 03D1019490 / CAP 7195577 / ISO 15189:2012 – 3531.01
Caris MPI, Inc. d/b/a Caris Life Sciences ©2014 Caris Life Sciences. All rights reserved. TN0034 .5 / Revision December 18, 2014
Physician will be solely responsible for confirming that legally-effective informed consent has been obtained from the patient or his/her authorized representative as required by applicable
state law. By ordering a test from Caris Life Sciences, physician certifies that this consent is in place and that test results will be used and disclosed only in accordance with applicable law.
Menu of Services
While every attempt is made to keep this requisition current, the definitive list of assays included in each profile and list of available biomarkers can be found online at
www.CarisMolecularIntelligence.com/profilemenu. Before ordering testing services, please refer to the profile menu online to view the most up-to-date listing of biomarkers
that will be performed. Tests may vary if insufficient tumor samples are submitted. Please refer to the specimen requirements below for more information.
MI Profile™
IHC
FISH / CISH
AR, cMET, EGFR (H-score; NSCLC only),
EGFR (excluding NSCLC), ER, ERCC1 (ovarian only),
HER2, MGMT (excluding glioma), MLH1 (CRC only),
MSH2 (CRC only), MSH6 (CRC only), PD-1, PD-L1, Pgp,
PMS2 (CRC only), PR, PTEN, RRM1, SPARCm, SPARCp,
TLE3, TOP2A (excluding breast), TOPO1, TS, TUBB3
1p19q# (glioma only);
cMET#, HER2#,
TOP2A# (breast only),
ALK# (NSCLC only),
ROS1# (NSCLC only)
Mutational Analysis
Next-Generation Sequencing
Other
See MI Profile™ Next-Generation
Sequencing Genes below.
EGFRvIII (Frag. Analysis; glioma only),
IDH2 (SangerSeq; glioma only),
MGMT Methylation Analysis
(PyroSeq; glioma only)
MSI (Frag. Analysis; CRC only)
# Assay may be performed by an external reference laboratory.
Next-Generation Sequencing Cancer Service
Additional Next-Generation Sequencing Genes
(excluded from MI Profile™)
MI Profile™ Next-Generation Sequencing Genes
ABL1
BRCA1*
EGFR
GNA11
JAK2
MPL
PTEN
CDH1
NPM1
AKT1
BRCA2*
ERBB2 (HER2)
GNAQ
KDR (VEGFR2)
NOTCH1
RET
ERBB4
PTPN11
ALK
BRAF
FGFR1
GNAS
cKIT
NRAS
SMO
FBXW7
RB1
APC
CSF1R
FGFR2
HRAS
KRAS
PDGFRA
TP53
HNF1A
SMAD4
ATM
CTNNB1
FLT3
IDH1
cMET
PIK3CA
VHL
JAK3
SMARCB1
STK11
In certain instances, some biomarkers included in the MI Profile, Next-Generation Sequencing Cancer Service or genes ordered individually will not associate with commercially available
cancer therapies or clinical trials.
* May not be available for Medicare patients. Medicare only reimburses BRCA1-2 for breast and ovarian cases only.
Formalin Fixed Paraffin Embedded (FFPE) Samples
Sufficient tumor must be present to complete all analysis. If you have any questions, please contact Client Services at (888) 979-8669.
S P ECI ME N TY PE
SP E C I M E N R E QU I R E M E N T S
Fixed Tissue
One (1) tumor-containing formalin fixed paraffin embedded block (FFPE) from most recent surgery or biopsy. Successive four (4) micron sections will be created from the block until sufficient material for the testing orders is obtained. For the molecular analysis, tumor cells will be excised by microdissection until a total area of at least 50mm2 is obtained.
Core Needle Biopsy
Four to six (4-6) biopsies formalin fixed paraffin embedded
• 18 gauge needle preferred
Fine Needle Aspirate (FNA)
One (1) formalin fixed paraffin embedded block containing sufficient tumor
Unstained Slides
Unstained, positively charged, unbaked slides from one single, tumor-containing formalin fixed paraffin embedded block; 4 micron sections
• MI Profile™ - 55 slides
• Next-Generation Sequencing only - 15 slides
Note: At least a 5mm x 5mm section of tissue per slide is required. For small biopsies (tissue area < 5 mm x 5 mm) please cut two sections
per slide for at least one half of the slides to ensure sufficient material for molecular assays.
Malignant Fluid
One (1) formalin fixed paraffin embedded cell block containing sufficient tumor.
Formalin Samples
Sufficient tumor must be present to complete all analysis. If you have any questions, please contact Client Services at (888) 979-8669.
S P E CI ME N TY PE
SP E C I M E N R E QU I R E M E N T S
Fresh Tissue
Two (2) or more samples with a minimum thickness of ~3mm (height, width, length) and submit in 10% neutral buffered formalin.
Core Needle Biopsy
Four to six (4-6) biopsies
• 18 gauge needle preferred
Bone/Bone Metastasis
Two (2) or more samples with minimum thickness of 3mm (height, width, length) and submit in 10% neutral buffered formalin (DO NOT DECALCIFY)
Insufficient Specimen Quantity – Prioritization of Tests
In the event that a specimen is received with an insufficient quantity of tissue or insufficient percent tumor required to perform the entire profile or individual tests indicated on the requisition,
Caris Life Sciences® will fax the ordering physician the proposed list of tests. The physician may amend this list to include any tests that are offered within the test menu. The ordering physician should review
the proposed list of tests within 72 hours in order to provide timely results. Please note: turnaround time may be longer for specimens with limited tissue.
In certain circumstances, CMS requires that Caris Life Sciences® bill the hospital for the technical component and the clinical laboratory services component.
For more information, please call (888) 979-8669. For a complete list of CPT codes, please visit www.CarisMolecularIntelligence.com/billing_information.
4610 South 44th Place, Suite 100 / Phoenix, Arizona 85040 / (888) 979-8669 / Fax: (866) 479-4925 / CLIA 03D1019490 / CAP 7195577 / ISO 15189:2012 – 3531.01
Caris MPI, Inc. d/b/a Caris Life Sciences ©2014 Caris Life Sciences. All rights reserved. TN0034 .5 / Revision December 18, 2014