The Food and Drug Administration (FDA) has granted market authorization to an in vitro diagnostic test that detects HIV-1 drug resistance mutations (DRM), which may help clinicians tailor HIV therapy for their patients.
The Sentosa SQ HIV-1 Genotyping Assay (Vela Diagnostics) is intended for use in detecting HIV-1 genomic mutations in the protease, reverse transcriptase and integrase regions
of the pol gene. This test is used in conjunction with therapeutic management of patients diagnosed with HIV-1 Group M infection with viral loads of at least 1000 RNA copies/mL in EDTA plasma specimens.
“The ability to rationally select treatments for patients about to start or already taking antiviral therapy provides another tool in our ongoing fight against HIV” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Today’s authorization can help healthcare providers better tailor drug treatment for patients who are beginning antiviral therapy and also for those who have developed resistance to HIV drugs by helping to identify mutations in the HIV-1 virus that can impact the effectiveness of certain drugs.”
Market clearance of the Sentosa SQ HIV-1 Genotyping Assay was granted based on a review of data that showed a greater than 95% sensitivity and specificity in detecting 342 HIV drug-resistant mutations. The Company states that the test can deliver clinically relevant results in 2 days, however clinical observations, patient history and other lab evidence should all be considered before making treatment decisions.
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