Hepatitis C Virus LabCorp Background and Capabilities

Hepatitis C Virus
LabCorp Background and
Capabilities
Esoterix Clinical Trials Services (Esoterix) is a division
of LabCorp, an independent clinical laboratory
LabCorp’s Platform
220,000 customers 31,000 employees
1,500 patient centers 440,000 samples per day
40 years
Our mission is to be a leading provider of high science laboratory
services that support clinical decision-making, enhance the
management of laboratory information, and improve patient care.
Esoterix is a leading provider of
laboratory testing for clinical trials
Central Labs
Dedicated labs for
clinical trials
Cranford, NJ
Mechelen, Belgium
Beijing, China
Singapore
Broad, validated
test menu
Biomarker
Discovery
Esoteric Testing
Bioanalytical
Labs
8 Centers of Excellence
Small and large molecule
Discovery and development
Coagulation
Endocrinology
Oncology
Infectious disease
Anatomic pathology
Molecular pathology
Flow cytometry
Method development
and validation
GLP biomarker services
Companion
Diagnostics
Discovery, development,
commercialization
FDA experience
MS-based assays
IVD Trial Participation
LC/MS/MS
Non-GLP discovery
services
Cell-based assays
Global expertise:
Cranford, NJ
Mechelen, Belgium
San Diego, CA
West Trenton, NJ
Successful PMA submission
40,000 ft2 biorepository
Test method
harmonization
Commitment
to Quality
Integrated
Data
Management
Dedicated
Project
Management
Esoterix has unique qualifications
to support clinical trials
Scientific
Expertise
Global Scale and
Logistics
Relevant
Experience
Near Patient
Testing
Comprehensive test menu
27 sites on 5 continents
4,300 studies
1,500 patient centers
8 Centers of Excellence
Clearstone acquisition
provides wholly owned
labs in China and
Singapore
840 international studies
Large courier network
725 active trials
Economies of scale
Dedicated development
and validation resources
PBMC networks
Data mart with over 1.2MM
clinical results daily
Biomarker co-prevalence
Protocol design
49,000 sites
Able to cost effectively
deliver a sample globally
Data Analytics
Standardization of
analytics and IT systems
25 years CT experience
Companion diagnostic
co-development
Unique model for Ph I/II
and Ph IIIb/IV studies
Identification of
investigators
Patient recruitment
Scientific data queries
Global network - 27 labs on 5 continents
Dedicated central labs have the
broadest test menu in the industry
Broad validated test menu
Cranford, NJ
57,897 sq ft
Mechelen, Belgium
33,000 sq ft
•
Comprehensive safety/monitoring labs
•
Automated high throughput test systems
•
Proteins, nucleic acids, cell analysis
•
Logistics hub for LabCorp centers of excellence
•
Custom sponsor specific method validation
Test method harmonization
Beijing, China
25,000 sq ft
Singapore
7,000 sq ft
•
Testing standardized on same platforms
•
Global ranges in place for over 80 analytes
•
Monthly global inter-lab proficiency testing
•
Correlation studies where needed
Global study support
•
Single global database
•
Global project management services
•
Global data management
HCV
Experience and Capabilities
HCV Experience
LabCorp has a strong heritage in the support of
HCV clinical development programs
• Leading global laboratory provider of HCV therapeutic trials
– Multiple global, pivotal interferon trials
– Ongoing Direct-Acting Antiviral (DAA) studies
• Supported multiple HCV diagnostic clinical trials
• Close interactions with manufactures of HCV test kits/reagents to optimize and validate
performance
• First reference laboratory to launch HCV genotyping assay for strain typing
• First reference laboratory to commercialize HCV PCR viral load testing
• First reference laboratory to commercialize real time PCR HCV viral load assays
• First and most sensitive (2 IU/mL) molecular qualitative assay for HCV (National Genetics
Institute)
• Proprietary serum pooling technology for pre-seroconversion viral screening (NGI)
Summary of HCV Assays
•
•
•
•
•
Genotype and Phenotype Resistance Testing
IL28b
Genotype/Subtyping
Viral Load
HCV diagnosis, quantitation and blood screening
– UltraQual, SUPERQUANT & QuantaSure assays
• Fibrosis: FibroSure
• Standard liver function testing
• Bioanalytical, Immunoanalytical, Biomarker
HCV Resistance Assays Monogram Biosciences
• Monogram Biosciences is a LabCorp Center of Excellence focused on
Virology and Infectious Disease
– A leader in antiviral drug resistance testing
– Resistance testing for all approved HIV drugs since 2000
– Science driven: 50 peer-reviewed publications and conference
presentations annually
• Monogram has developed genotype and phenotype resistance assays
for the three lead targets of HCV direct acting antivirals (DAAs)
– NS5B: the polymerase that catalyzes the synthesis of new RNA early in the
HCV replication process
– NS3/4A: the protease that catalyzes the cleavage of newly formed HCV
polyprotein during the replication process
– NS5A: a factor crucial to the formation of the replication complex and
other aspects of the HCV life cycle
Example of Genotype Resistance Data
Sequence Analysis
Client:
Example Report
NS5B population sequence analysis
MGRM ID
MGRM GT
06-0293-BC
06-0294-BC
06-0298-BC
06-0300-BC
08-0742-HB
08-0743-HB
08-0762-HB
08-0769-HB
08-0790-HB
08-0793-HB
1a
1a
1a
1a
1b
1b
1b
1b
1a
1b
NS5B predicted amino acid differences from reference sequence (1b Con1, 1a H77)
GeneSeq® HCV NS5B Assay
Project: Example Report
S5T, V11V/I, A15A/V, C46S, S90D, K98R, A117N, L184Q, R300Q, Q309R, N444D, S473S/T, S506N, L536L/I, G543S, R544Q, T552T/M, H566R, L588Y
A117S, K212R, G376D, S431G, N444D, S506N, R544Q, H566R
C46S, D66D/G, C110S, V116I, A117N, K124N, S189S/N, K212G, R270K, R300K, Q309R, A327Q, V405I, F415Y, I434M, N444D, S506N, R517K, I520V, G543S, R544Q, H566R
A117N, K212R, S335N, N444D, G480S, S506N, R531K, G543S, F574L
A15S, T19S, L36M, L47Q, M71V, R98K, A210S, N231S, V235T/I, T267F, A300S, E333A, A338V, K355Q, V499A, R510K, T520L, K523R, S549S/G
T19S, N35G, L36M, V37I, L47Q, K106K/R, V116I, T130S, V147I, N206K, A210S, N231S, I262V, A300T, E333A, A338V, K355Q, E357A, S476T, G480S, V499T, R510K, T520I,
A15S, T19S, L36M, L47Q, M71V, R98K, D135S, I138V, A210S, N231S, V235V/I, A252A/V, I262V, T267F, A300S, E333A, A338V, K355Q, M414M/L, V499A, S506N, R510K, Q5
T19S, L36M, L47Q, L57Q, K81R, R98R/K, S113S/G, T130S, A210S, N231S, A246A/T, I262V, A300T, E333A, A338V, K355Q, A421V, I424I/V, M426L, C451N/T/Y/S, S487A, V4
S5T, V11I, Q47L, A117N, L184I, S210A, R300Q, Q309R, N444D, R531R/K
I11V, T19S, L36M, L47Q, A73V, A210S, C213N, A218S, A300S, C316H, V321I, E333A, A338V, K355Q, R510K, R531K, Q544R, S549G, S556S/G, L564V, R566H, W574L
Scientific Leadership
IL28B, Genotype/Subtype
and Viral Load
• IL28B
– Assay profiles the rs12979860 SNP
(3kb upstream of the IL28B gene) for
CC, CT and TT genotypes using realtime PCR from blood or buccal swab
samples
• Genotype/Subtyping: Types 1-6
– Bayer Diagnostics Versant HCV 2.0
(LiPA)
• Viral Load
– Roche COBAS® AmpliPrep/COBAS®
TaqMan® HCV Test
Additional Capabilities
• HCV diagnosis, quantitation and blood screening
(National Genetics Institute)
– UltraQual, SUPERQUANT & QuantaSure assays
• Fibrosis: FibroSure
– A patented artificial intelligence algorithm predictive of
fibrosis and necroinflammatory activity in the liver
• Standard liver function testing
Early Discovery / Preclinical Services
Tandem Labs
Services
• Bioanalytical Small Molecules
– Over 35 LC/MS/MS systems
– Method development, method validation, sample analysis
– GLP and non-GLP preclinical
– Clinical
• Non-GLP Bioanalytical & Biomarker
– Discovery PK
– GLP (Q2 2009) and non-GLP preclinical
– Metabolite Profiling & ID
– Biomarker Discovery, Pathway ID and Quantitation
• Immunoanalytical & Biomarkers
– GLP
– ELISA, ECL – multiplexed, cell based assays
Summary
LabCorp provides clients with:
•
Proven experience in supporting sponsors’ HCV
development needs
•
Broad menu of all major tests critical for the
assessment of HCV
•
Robust scientific capability with active research in
resistance/phenotyping and technical evaluation
programs with major IVD manufactures
•
Global reach and logistics support with 27 sites
and staff on 5 continents