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FDA Authorizes New Type of Test for Drug-Resistant HIV

Drug resistance in HIV patients has nearly tripled since 2001

The FDA has approved a first-of-its-kind test to detect resistance to human immunodeficiency virus (HIV) drugs—a growing problem that now affects three out of every 10 HIV patients.

 The agency authorized marketing of the Sentosa SQ HIV Genotyping Assay (Vela Diagnostics USA Inc.), the first test to detect HIV-1 drug-resistance mutations using next generation sequencing (NGS) technology.

“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,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “However, according to a recent report from the Centers for Disease Control and Prevention and the World Health Organization, 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.”

The test can help providers better tailor treatment for new HIV patients as well as 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,” Dr. Marks said.

The new test detects mutations in genes of the HIV-1 virus from a sample of a patient’s blood using NGS. The FDA reviewed data from performance studies that demonstrated a greater than 95% sensitivity and specificity in detecting 342 HIV drug-resistant mutations and determined the Sentosa SQ HIV-1 Genotyping Assay provides a reasonable assurance of safety and effectiveness for its intended use.

Results of this test are intended to be used in conjunction with clinical observations, patient history, and other laboratory evidence to make patient management decisions.

NGS technologies allow rapid sequencing of large segments of an individual’s DNA. Unlike other laboratory tests that typically detect a single or a defined number of substances to diagnose a limited set of conditions, a single NGS test can identify thousands—even millions—of genetic variants.

Sources: FDA, November 5, 2019; FDA, December 2014

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