Hepatitis C Virus LabCorp Background and Capabilities
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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 Esoteric Testing Bioanalytical Biomarker Companion
Labs Discovery Diagnostics
Dedicated labs for 8 Centers of Excellence Small and large molecule Discovery and development Discovery, development,
clinical trials commercialization
Coagulation Method development GLP biomarker services
Cranford, NJ Endocrinology and validation FDA experience
Mechelen, Belgium Oncology MS-based assays
Beijing, China Infectious disease LC/MS/MS IVD Trial Participation
Singapore Anatomic pathology Global expertise:
Molecular pathology Non-GLP discovery Cranford, NJ Successful PMA submission
Broad, validated Flow cytometry services Mechelen, Belgium
test menu San Diego, CA 40,000 ft2 biorepository
Cell-based assays West Trenton, NJ
Test method
harmonization
Commitment Integrated Dedicated
to Quality Data Project
Management Management
Esoterix has unique qualifications
to support clinical trials
Scientific Global Scale and Relevant Near Patient Data Analytics
Expertise Logistics Experience Testing
Comprehensive test menu 27 sites on 5 continents 4,300 studies 1,500 patient centers Data mart with over 1.2MM
clinical results daily
8 Centers of Excellence Clearstone acquisition 840 international studies Large courier network
provides wholly owned Biomarker co-prevalence
Dedicated development labs in China and 725 active trials Economies of scale
and validation resources Singapore Protocol design
49,000 sites Standardization of
Able to cost effectively analytics and IT systems Identification of
deliver a sample globally 25 years CT experience investigators
Unique model for Ph I/II
PBMC networks Companion diagnostic and Ph IIIb/IV studies Patient recruitment
co-development
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 Mechelen, Belgium • Comprehensive safety/monitoring labs
57,897 sq ft 33,000 sq ft
• 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 Singapore
25,000 sq ft 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 cycleExample of Genotype Resistance Data
Sequence Analysis
Client: Example Report
NS5B population sequence analysis
GeneSeq® HCV NS5B Assay
MGRM ID MGRM GT NS5B predicted amino acid differences from reference sequence (1b Con1, 1a H77) Project: Example Report
06-0293-BC 1a S5T, V11V/I, A15A/V, C46S, S90D, K98R, A117N, L184Q, R300Q, Q309R, N444D, S473S/T, S506N, L536L/I, G543S, R544Q, T552T/M, H566R, L588Y
06-0294-BC 1a A117S, K212R, G376D, S431G, N444D, S506N, R544Q, H566R
06-0298-BC 1a C46S, D66D/G, C110S, V116I, A117N, K124N, S189S/N, K212G, R270K, R300K, Q309R, A327Q, V405I, F415Y, I434M, N444D, S506N, R517K, I520V, G543S, R544Q, H566R
06-0300-BC 1a A117N, K212R, S335N, N444D, G480S, S506N, R531K, G543S, F574L
08-0742-HB 1b A15S, T19S, L36M, L47Q, M71V, R98K, A210S, N231S, V235T/I, T267F, A300S, E333A, A338V, K355Q, V499A, R510K, T520L, K523R, S549S/G
08-0743-HB 1b T19S, N35G, L36M, V37I, L47Q, K106K/R, V116I, T130S, V147I, N206K, A210S, N231S, I262V, A300T, E333A, A338V, K355Q, E357A, S476T, G480S, V499T, R510K, T520I,
08-0762-HB 1b 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
08-0769-HB 1b 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
08-0790-HB 1a S5T, V11I, Q47L, A117N, L184I, S210A, R300Q, Q309R, N444D, R531R/K
08-0793-HB 1b I11V, T19S, L36M, L47Q, A73V, A210S, C213N, A218S, A300S, C316H, V321I, E333A, A338V, K355Q, R510K, R531K, Q544R, S549G, S556S/G, L564V, R566H, W574LScientific 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 real-
time 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 TestAdditional 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 testingEarly 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 assaysSummary
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 continentsYou can also read
