LONDON – Twenty years on from sequencing of the first draft of the human genome and the associated hype, 2019 was the year that the science of genomics truly began to make an impact in health care.
Singapore-based Vela Diagnostics Holding Pte. Ltd. has received U.S. FDA authorization via the de novo approval pathway for an in vitro diagnostic test to detect HIV-1 genomic drug resistance mutations (DRMs). The Sentosa SQ HIV-1 Genotyping Assay – the first HIV-1 genotyping next-generation sequencing (NGS) assay to win an FDA nod – uses plasma of patients infected with HIV-1 to detect HIV-1 Group M DRMs in the protease, reverse transcriptase and integrase regions of the pol gene in a single test.
Singapore-based Vela Diagnostics Holding Pte. Ltd. has received U.S. FDA authorization via the de novo approval pathway for an in vitro diagnostic test to detect HIV-1 genomic drug resistance mutations (DRMs).
