Labcorp-Monogram Biosciences
Monogram Biosciences is a clinical reference laboratory and research organization focused on virologic resistance testing, diagnostic assay development, and services that support individualized medicine and drug development. The organization offers genotypic and phenotypic viral resistance testing, combined pheno/genotypic reports from single samples, neutralizing antibody cell-based assays, viral load testing, next-generation sequencing, clinical-trial laboratory services, secure online result reporting, and reimbursement assistance. The laboratory operates a CAP- and CLIA-accredited clinical reference laboratory and collaborates with academic, industry, and government partners on research and assay development.
Industries
N/A
Nr. of Employees
medium (51-250)
Labcorp-Monogram Biosciences
345 Oyster Point Boulevard, South San Francisco, CA 94080
Patents
Adjusted multi-biomarker disease activity score for inflammatory disease assessment
US-12392785-B2
View Details
Adjusted multi-biomarker disease activity score for inflammatory disease assessment
US-12392785-B2
View DetailsProducts
Combined genotypic and phenotypic resistance assay (single-sample)
Laboratory workflow that produces both genotypic sequencing and phenotypic drug susceptibility results from the same patient specimen, with a reconciled net assessment to resolve genotype/phenotype discordance.
Genotypic sequencing assays (clinical)
Sequencing-based clinical assays for identification of viral mutations associated with drug resistance; assay variants provide different genomic coverage (protease and reverse transcriptase; comprehensive assays may include integrase) and are validated for use at defined viral-load thresholds (approximately ≥500 copies/mL).
Phenotypic susceptibility assay (clinical)
Direct phenotypic measurement of viral susceptibility to antiviral drugs performed in a clinical laboratory setting to inform treatment selection.
Pseudovirus-based neutralizing antibody assay
Cell-based neutralization assay that uses pseudovirions and a luminescent reporter to measure functional neutralizing antibody activity in serum or plasma.
Secure web-based result reporting portal
Provider-facing portal for retrieval, printing, and downloading of patient test reports with search and historical tracking features.
Combined genotypic and phenotypic resistance assay (single-sample)
Laboratory workflow that produces both genotypic sequencing and phenotypic drug susceptibility results from the same patient specimen, with a reconciled net assessment to resolve genotype/phenotype discordance.
Genotypic sequencing assays (clinical)
Sequencing-based clinical assays for identification of viral mutations associated with drug resistance; assay variants provide different genomic coverage (protease and reverse transcriptase; comprehensive assays may include integrase) and are validated for use at defined viral-load thresholds (approximately ≥500 copies/mL).
Phenotypic susceptibility assay (clinical)
Direct phenotypic measurement of viral susceptibility to antiviral drugs performed in a clinical laboratory setting to inform treatment selection.
Pseudovirus-based neutralizing antibody assay
Cell-based neutralization assay that uses pseudovirions and a luminescent reporter to measure functional neutralizing antibody activity in serum or plasma.
Secure web-based result reporting portal
Provider-facing portal for retrieval, printing, and downloading of patient test reports with search and historical tracking features.
Services
Laboratory testing and reporting services tailored to support HIV, HCV, oncology, and other viral clinical trials, including resistance and neutralizing antibody assays.
Sequencing services for viral genotyping and research applications to support resistance analysis and characterization.
Regulatory submission assistance for investigational and marketing applications related to antiviral and vaccine development, coordinated with laboratory data.
Quantitative viral RNA testing with reflex ordering to downstream resistance assays when viral load exceeds assay-specific thresholds to ensure sufficient material for downstream testing.
Provider portal providing rapid, secure, searchable, and downloadable access to patient test reports for ordering healthcare providers.
Operational service to verify coverage, obtain prior authorization, prepare appeals, and coordinate documentation to support patient and provider reimbursement for testing.
Laboratory testing and reporting services tailored to support HIV, HCV, oncology, and other viral clinical trials, including resistance and neutralizing antibody assays.
Sequencing services for viral genotyping and research applications to support resistance analysis and characterization.
Regulatory submission assistance for investigational and marketing applications related to antiviral and vaccine development, coordinated with laboratory data.
Quantitative viral RNA testing with reflex ordering to downstream resistance assays when viral load exceeds assay-specific thresholds to ensure sufficient material for downstream testing.
Provider portal providing rapid, secure, searchable, and downloadable access to patient test reports for ordering healthcare providers.
Operational service to verify coverage, obtain prior authorization, prepare appeals, and coordinate documentation to support patient and provider reimbursement for testing.
Expertise Areas
- Virologic resistance testing
- Genotypic sequencing and interpretation
- Phenotypic drug susceptibility testing
- Neutralizing antibody functional assays
Key Technologies
- Next-generation sequencing (NGS)
- Amplicon-based viral sequencing (pol region, protease, RT, integrase)
- RT-qPCR/viral RNA quantitation
- Pseudovirus neutralization assays
News & Updates
Company scientists have authored more than 200 articles in peer-reviewed journals.
Operates a clinical reference laboratory with CAP and CLIA accreditation.
Company scientists have authored more than 200 articles in peer-reviewed journals.
Operates a clinical reference laboratory with CAP and CLIA accreditation.