FDA grants de novo designation to NGS HIV-1 genotyping assay
December 2019—Vela Diagnostics received FDA authorization to market its in vitro diagnostic test for the detection of HIV-1 genomic drug resistance mutations. The Sentosa SQ HIV-1 Genotyping Assay uses the plasma of patients infected with HIV-1 to detect HIV-1 Group M drug resistance mutations in the protease, reverse transcriptase, and integrase regions of the pol gene, in a single test. It is the first HIV-1 genotyping NGS assay to receive marketing authorization from the FDA. In a Nov. 5 statement, Vela acting CEO and chairman of the board Sam Dajani called the FDA’s granting of the de novo designation to the NGS assay “a major milestone in HIV diagnostics.” “With the Sentosa SQ HIV-1 Genotyping Assay, laboratories will now have a sample-to-report solution to aid in monitoring and treating HIV-1 infection,” he said. The assay is validated on the Sentosa NGS workflow that enables automated RNA extraction, PCR setup, library construction, template preparation, sequencing, data analysis, and automated reporting.