FDA Gives Nod for Breakthrough HIV Test

Vela Diagnostics will go down in history as bringing to market the first test capable of detecting human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next-generation sequencing (NGS) technology. The Fairfield, NJ-based company submitted the Sentosa SQ HIV Genotyping Assay for FDA market authorization in March. It is the first FDA-authorized HIV drug resistance assay that uses NGS technology. “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” said Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research. “Today’s authorization offers healthcare 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 bloodstream, and help keep patients with HIV healthy for many years." HIV drug resistance is a growing problem. Marks cited a recent report from the Centers for Disease Control and Prevention and the World Health Organization that found the global percentage of people living with HIV who have resistance to some HIV drugs has increased from 11% to 29% since 2001. "Today’s authorization can help health care providers bette...
Source: MDDI - Category: Medical Devices Authors: Tags: IVD Source Type: news