By staff writers

November 6, 2019 -- Vela Diagnostics USA has garnered U.S. Food and Drug Administration (FDA) marketing approval for its Sentosa SQ HIV-1 genotyping assay, a test designed to detect HIV-1 drug resistance mutations using next-generation sequencing (NGS) technology.

The FDA said the approval is its first for an HIV drug resistance assay using NGS technology. The Sentosa SQ HIV-1 genotyping assay is meant for use only in patients with HIV-1 who are about to start or are already taking antiviral therapy, according to the FDA. It's not intended for diagnosing infection with HIV. The test results are intended to be used in conjunction with clinical observations, patient history, and other laboratory evidence to make patient management decisions, the FDA noted.

Before granting marketing authorization, the FDA reviewed data from performance studies that demonstrated more than 95% sensitivity and specificity for detecting 342 HIV drug-resistant mutations.

Mylan, Atomo 15-minute HIV self-test gets WHO backing
Mylan and Atomo Diagnostics' handheld, rapid HIV test has received prequalification approval from the World Health Organization (WHO), which signifies...
NIH funds creation of granuloma lab model for TB and HIV
The U.S. National Institutes of Health (NIH) is funding work by the Texas Biomedical Research Institute to develop a laboratory model that will improve...
Avioq launches HIV profiling assay in Europe
Avioq has launched its VioOne HIV Profile supplemental assay for confirming types of HIV in European Union countries and other nations that accept the...
Will new HIV recommendations boost test volume?
New recommendations released June 11 from the U.S. Preventive Services Task Force continue to strongly advise HIV screening for adolescents and adults,...
STD test market grows with incidence, new tech
The need to make screening and testing of sexually transmitted diseases (STDs) more accessible worldwide is creating opportunities for manufacturers of...

Copyright © 2019

Last Updated np 11/6/2019 12:32:37 PM

Register below for our weekly Letter from the Editor to receive the latest Clinical Lab news and insights.