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FDA approved HIV-1 genotyping assay, a 1st NGS test

The U.S. Food and Drug Administration authorized marketing first (NGS) next-generation sequencing (NGS) technology for the detection of human immunodeficiency virus (HIV) Type-1 drug resistance mutations. The Sentosa SQ HIV Genotyping Assay granted De Novo marketing authorization to Vela Diagnostics.

It is the first HIV drug resistance assay that uses NGS technology for marketing in the U.S. The test is for use only in HIV-1 patients who are about to start or already taking antiviral therapy as per FDA approval.

“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, director of FDA’s Center for Biologics Evaluation and Research, said in a press release. “The right combination of antivirals can lower viral loads, or the amount of virus in the bloodstream, and help keep patients with HIV healthy for many years.”

As per WHO, People living with HIV/AIDS 37.9 million people living with HIV/AIDS worldwide in 2018 and according to the CDC, there were more than 1 million Americans living with HIV in 2016.

FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. 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. 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.”

As per Vela, an earlier version of the Sentosa SQ HIV Genotyping Assay received the CE mark and was approved by the TGA (Australian Therapeutic Goods Administration) and HSA (Singapore Health Sciences Authority) in 2017. In August 2019, the assay received approval from the Thai FDA.

Posted in Medical Device.

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