FDA OKs HIV Genotyping Assay

FDA has cleared a de novo marketing request from Vela Diagnostics USA for its Sentosa SQ HIV Genotyping Assay for detecting human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology. The assay is the first HIV drug resistance assay that uses NGS technology.

The assay detects mutations in genes of the HIV-1 virus from a sample of a patient’s blood using NGS. “Understanding the mutations in the virus can help healthcare providers select an effective combination of drugs in an ART [anti-retroviral thrapy] regimen and indicate which drugs may no longer be effective against the mutated HIV-1 virus,” an FDA release says. “The FDA reviewed data from performance studies, which demonstrated a greater than 95% sensitivity and specificity in detecting 342 HIV drug resistant mutations and determined the Sentosa SQ HIV-1 Genotyping Assay provides a reasonable assurance of safety and effectiveness for its intended use.”