FDA Clears Test For HIV-1 Drug Resistance
The FDA cleared a test to detect HIV type 1 drug resistance mutations using next-generation sequencing (NGS) technology (Sentosa SQ HIV Genotyping Assay, Vela Diagnostics).
The Sentosa assay uses the plasma of HIV-positive patients to detect HIV-1 Group M resistance mutations in the protease, reverse transcriptase and integrase regions of the pol gene. It is the first and only HIV-1 genotyping NGS technology authorized for