FDA Authorizes Marketing of an HIV-1 Drug Resistance Test

The US Food and Drug Administration (FDA) has authorized marketing of the Sentosa SQ HIV Genotyping Assay, a test that detects HIV-1 drug resistance mutations using next-generation sequencing technology. The assay is the first HIV drug resistance test using next-generation sequencing technology to be authorized for marketing in the United States. The FDA granted the marketing authorization to Vela Diagnostics USA Inc.

The Sentosa SQ HIV-1 Genotyping Assay detects drug resistance mutations in patients who are undergoing or about to undergo antiviral therapy. The assay detects mutations in the genetics of HIV in a sample of blood using next-generation sequencing.

The FDA examined data from performance studies demonstrating a greater than 95% sensitivity and specificity in detecting 342 drug resistance mutations. This led to the conclusion that the assay provides reasonable assurance of safety and effectiveness for its intended use.

The FDA noted in its statement on the authorization that the assay is not intended for diagnosing infection with HIV. It was also emphasized that the results of the test should be used in combination with clinical observation, patient history, and accompanying laboratory evidence when making patient management decisions.

The assay was evaluated through the de novo premarket review pathway, a regulatory pathway the FDA employs for devices of a new type. The FDA is establishing special controls, which are requirements that test developers must meet with respect to accuracy, reliability, and effectiveness for tests intended to identify HIV mutations. The FDA’s decision creates an entirely new regulatory classification in which subsequent devices of the same type will be classified within.

“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,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research said in the FDA’s statement.