Posted by Michael Wonder on 06 Nov 2019
FDA authorises marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations
5 November 2019 - Today, the U.S. FDA authorised marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing technology.
The Sentosa SQ HIV Genotyping Assay is the first HIV drug resistance assay that uses NGS technology that the FDA has authorised for marketing in the U.S.
The FDA reviewed data for the Sentosa SQ HIV Genotyping Assay through the de novo premarket review pathway, a regulatory pathway for devices of a new type.
