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 interrogates the viral archive using 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 nucleoside reverse transcriptase inhibitors (NRTIs), nonnucleoside reverse transcriptase inhibitors (NNRTIs), integrase inhibitors (INIs) and protease inhibitors (PIs) when considering regimen switches in virologically suppressed patients due to:
- Side effects
- Adverse events
- Regimen simplification
- Drug-drug interactions
- Concern for long-term toxicities
- Regimen intolerance
The Viral Archive—A Second Source of Resistance Information
Differences can exist between the viral population circulating in the plasma and the proviral DNA archived in infected cells.
- Viral loads and standard resistance assays analyze viral RNA in plasma. GenoSure Archive analyzes archived HIV-1 proviral DNA embedded in host cells during virus replication.
- GenoSure Archive is performed by amplifying cell-associated HIV-1 DNA from infected cells in whole blood samples then employing NGS technology to analyze the HIV-1 polymerase region, including the full-length protease and integrase coding regions and amino acids 1-400 of reverse transcriptase. See the special sample handling procedures for GenoSure Archive.