Monogram Biosciences
Drug and Vaccine Development Support
Monogram Biosciences
• Monogram was founded in November 1995 and acquired by LabCorp in August
2009
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Monogram is a LabCorp Center of Excellence with a focus on
Virology and Infectious Disease
• HIV – Leader in drug resistance
• HCV – Comprehensive portfolio
• Respiratory viruses – Novel services
•
Clinical Reference Laboratory
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CLIA/CAP accredited
Testing for clinical patient management
and drug/vaccine development
•
Monogram’s assays for clinical trials are offered
directly at Monogram and through Covance Clinical Trials Services
•
Monogram has supported development of every clinically available HIV
antiretroviral
Covance Clinical Trial Services Offers a Broad
Range of Clinical Trial Support
Central Labs
Dedicated labs for
clinical trials
Cranford, NJ
Mechelen, Belgium
Beijing, China
Singapore
Broad, validated
test menu
Bioanalytical Labs
Esoteric Testing
Biomarker
Discovery
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
History of Monogram HIV Assay Offerings
Monogram HIV Assays and Services for
Clinical Research and Development
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Protease/Reverse Transcriptase Inhibitor Resistance Assays
– PhenoSense ® (phenotype; infectivity assay)
– GenoSure® MG (genotype; DNA sequencing assay)
– PhenoSense ® GT≤ (combination phenotype/genotype)
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GenoSure Archive – DNA resistance testing for patients with undetectable VL
Entry Inhibitor Susceptibility Assays (inhibitors of attachment, co-receptor engagement and membrane fusion)
Trofile®, Trofile ® DNA (co-receptor tropism determination)
Integrase Inhibitor Resistance Assays (phenotype; genotype)
GenoSure PRIme (combination PR/RT, INI genotype)
Assembly Inhibitor Resistance Assays (phenotype; genotype)
Replication Capacity Assays (viral “fitness” ) for HIV
Subtype/clade determinations (A, B, C, D, F, AE, AG, BF, etc.)
Neutralizing Antibody Assay for HIV
Quasispecies characterization…clonal analysis
Next Generation Sequencing (minor variant characterization)
HIV Curative Strategy assays
PhenoScreen® Novel Drug Testing (lead compound characterization)
Other supportive assays – Viral Load (Roche COBAS, Abbot Real Time), RVP
Summary of HCV Assays
•
Population and Next Generation Sequencing (NS3/4A, NS5A, NS5B)
• Phenotypic resistance testing (luciferase reporter replicon assays)
• Replication Capacity (viral “fitness” for HCV)
• IL28b allele determination
• Genotyping/subtyping (remove LiPA)
• Viral load (multiple platforms and assay available)
• HCV diagnosis, quantitation and blood screening
• UltraQual, SUPERQUANT & QuantaSure assays
• Fibrosis: FibroSure (necro-inflammatory markers)
• Standard liver function testing (ALT,AST)
• Bioanalytical, immunoanalytical, biomarker
HCV Resistance Assays: GT 1a/1b
Assay
RUO
CLIA/CAP
GenoSure NS3/4A
RUO
CLIA/CAP
GenoSure NS5A
RUO
CLIA/CAP
GenoSure NS5B
RUO
CLIA/CAP
PhenoSense NS3 protease
RUO
PhenoSense NS5A
RUO
PhenoSense NS5B
RUO
Next Generation Sequencing
RUO
CLIA/CAP
HCV Resistance Assays: GT2, 3, 4, 6
Assay
Development / RUO / CLIA/CAP
GT2a
GT2b
GT3a
GT4
GT6
GenoSure NS3/4A
CLIA/CAP
CLIA/CAP
DEV
(NGS)
DEV
(NGS)
DEV
(NGS)
GenoSure NS5A
CLIA/CAP
CLIA/CAP
DEV
(NGS)
RUO
DEV
(NGS)
GenoSure NS5B
RUO
RUO
RUO
RUO
PhenoSense NS5A
DEV
DEV
DEV
RUO
(subset)
PhenoSense NS5B
RUO
RUO
RUO
RUO
(subset)
PhenoSense NS3 protease
Next Generation Sequencing
CLIA/CAP CLIA/CAP CLIA/CAP CLIA/CAP CLIA/CAP
Monogram Biosciences
Respiratory Virus Testing Capabilities
•
GenMark Respiratory Virus Panel (RVP)
– Validated in multiple sample types for up to 14 virus targets
– Can test for 10, 14 or 19 virus panels
– Includes subtyping of Influenza and RSV
– Validated for Nasopharyngeal Swabs, Blown Mucus and Nasal Swabs
– Validation of blown mucus in progress
• Cell-Based Neutralizing Antibodies Assay
– High throughput
– Influenza A and B, RSV A and B
• qRT/PCR
– Qualitative/Quantitative qRT/PCR assays: for specific viruses, please
contact Monogram for more information
• Phenotyping
– RSV, Influenza A and B
– High throughput characterization of new and existing anti-viral compounds
against a panel of clinical isolates and reference strain
Oncology - VeraTag FFPE Assays
• Proximity-based immunoassays that quantitate protein expression
and/or protein complex formation in formalin-fixed, paraffinembedded (FFPE) specimens.
• Assays proprietary to Monogram
• The term VeraTag refers to the platform technology.
• HERmark refers specifically to HER2 total protein (H2T)
measurements for breast cancer
VeraTag Technology for Oncology Pathway
Profiling and Biomarker Development
Monogram’s Oncology Pharma partners include:
For more information:
Andrew Gale
galea@Labcorp.com