FDA: New HIV-1 Assay Authorized for Marketing in the United States

The US Food and Drug Administration has authorized marketing of the Sentosa SQ HIV Genotyping Assay to detect HIV-1 drug resistance mutations using next-generation sequencing (NGS) technology.

The new Assay is the first HIV drug resistance assay that uses NGS technology to be authorized for marketing in the United States. It can detect mutations in genes of the HIV-1 virus via a simple blood sample.

“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 offers health care providers a new tool in helping to select treatment options for their patients.”

This authorization comes after performance data demonstrated a greater than 95% sensitivity and specificity in detecting 342 HIV drug-resistant mutations; data also showed safety and effectiveness for the assay’s intended use.

“As a public health agency, the FDA is keenly aware of the threat of drug resistant infections and we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections,” said Amy Abernethy, MD, PhD, the FDA’s Principal Deputy Commissioner.

—Amanda Balbi

Reference:

FDA authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations [press release]. Silver Spring, MD: US Food and Drug Administration; November 5, 2019. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-next-generation-sequencing-test-detecting-hiv-1-drug-resistance. Accessed November 7, 2019.