A new test to detect drug resistance mutations in HIV-1 using next-generation sequencing (NGS) technology has been approved for marketing, according to a recent announcement from the U.S. Food and Drug Administration (FDA).

The Sentosa SQ HIV Genotyping Assay (Vela Diagnostics) is intended to help identify drug resistance in patients with HIV who are about to or are currently receiving antiretroviral therapy.

 
Blood Vials. Source: Getty Images

“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,” Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research at the FDA, stated in a press release. “Today’s authorization offers health care providers a new tool in helping to select treatment options for their patients. The right combination of antivirals can lower viral loads, or the amount of virus in the blood stream, and help keep patients with HIV healthy for many years.”

According to the FDA, which reviewed the Sentosa SQ HIV Genotyping Assay through the de novo reviews pathway, the assay had > 95% sensitivity and specificity for detecting 342 drug-resistant mutations. The device is an aid for monitoring HIV-1 infections in patients, rather than as a diagnostic device, they said.

“Today’s authorization 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 Dr. Marks.

The FDA also noted in its release that marketing approval for the Sentosa SQ HIV Genotyping Assay opens up a new regulatory classification for similar devices, and future devices can use the FDA 510(k) pathway to gain approval if they are the same type of device with the same intended use.

“The granting of the De Novo designation of our NGS assay by the U.S. FDA is a major milestone in HIV diagnostics,” Sam Dajani, acting CEO and chairman of the board at Vela Diagnostics, said in a company press release. “VELA strives to bring relevant products to clinicians to help patients around the world. With the Sentosa SQ HIV-1 Genotyping Assay, laboratories will now have a sample-to-report solution to aid in monitoring and treating HIV-1 infection.”

“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,” Amy Abernethy, MD, PhD, said FDA Principal Deputy Commissioner, stated in a press 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.”