FDA Clears Next-Gen Assay to Detect HIV-1 Drug Resistance Mutations

Megan Brooks

Disclosures

November 06, 2019

The US Food and Drug Administration (FDA) has approved the Sentosa SQ HIV genotyping assay (Vela Diagnostics USA Inc) that uses next generation sequencing technology to detect HIV-1 drug resistance mutations from a blood sample.

Recent data suggest that the percentage of people living with HIV around the world that have resistance to some HIV drugs has increased from 11% to 29% since 2001, Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in a news release.

This new assay "can help health care 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," said Marks.

Sentosa SQ is the first HIV drug resistance assay that uses next generation sequencing technology that the FDA has authorized for use.

Results of performance studies show that the assay has > 95% sensitivity and specificity in detecting 342 HIV drug resistant mutations, the FDA said.

"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," FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said in the news release.

"This diagnostic provides a new way to select effective treatment options. The FDA remains committed to helping to make available to Americans more innovative medical products that help us face the challenges of managing HIV infection," she said.

The FDA reviewed the Sentosa assay under the de novo premarket review pathway, a regulatory pathway for new types of devices considered low-to-moderate risk. The FDA will develop special controls in addition to general controls that will help ensure the safety and effectiveness for the assay.

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