PR/RT/IN Resistance Testing
Monogram has three assays that sequence and analyze the PR, RT, and IN regions of the virus, providing information on four classes of drugs, protease inhibitors (PIs), nucleoside reverse transcriptase inhibitors (NRTIs), nonnucleoside reverse transcriptase inhibitors (NNRTIs), and integrase inhibitors (INIs):
GenoSure Prime is a comprehensive genotypic resistance test for four classes of HIV drugs, including PIs, NRTIs, NNRTIs, and INIs with resistance predictions based on Monogram’s proprietary genotypic assessment. This assessment is unique and is frequently updated through detailed analysis of Monogram’s vast genotypic/phenotypic database, as well as literature review and joint analyses of clinical trials data with our academic and pharmaceutical company collaborators.
The report form includes drug resistance information for all of the approved NRTIs, NNRTIs, PIs, and INIs. In addition, all amino acid changes observed relative to reference are reported for all of integrase, protease, and amino acids 1-400 of reverse transcriptase. The test is appropriate for the evaluation of patient specimens with HIV-1 viral loads of >500 copies/mL and is an excellent assay for clinical trial screening, because it provides mutations and resistance calls for PR, RT, and INIs in a single report from a single sample within 10 days.
GenoSure Archive is the newest suppression management offering by Monogram Biosciences. GenoSure Archive is designed to provide HIV-1 antiretroviral (ARV) drug resistance data when standard resistance testing cannot be performed due to inadequate plasma viral load.The assay exploits peripheral blood mononuclear cells (PBMCs) in whole blood to interrogate the viral archive, uses next-generation sequencing (NGS) methods to provide a list of the archived mutations, and then assigns susceptibility calls of "sensitive", "resistant", or "resistance possible" based on those mutations. GenoSure Archive provides valuable information for NRTIs, NNRTIs, INIs and PIs when regimen switches are being considered.
PhenoSense GT Plus Integrase is the first commercial assay to provide comprehensive genotypic and phenotypic drug resistance information for NRTIs, NNRTIs, PIs, and INIs from a single sample on a single report. The genotypic component evaluates the HIV-1 polymerase (pol) region, including the protease and integrase coding regions and amino acids 1-400 of reverse transcriptase. The phenotypic component evaluates the HIV-1 polymerase (pol) region, which provides a direct, quantitative measure of drug susceptibility for NRTIs, NNRTIs, PIs, and INIs. The report includes a net assessment for each drug, which resolves discordance (disagreement) between genotypic and phenotypic susceptibility results. This test is appropriate for the evaluation of patient specimens with HIV-1 viral loads ≥500 copies/mL.