NEW YORK (GenomeWeb) – Vela Diagnostics announced today that its next-generation sequencing-based Sentosa SQ HIV genotyping assay is now CE-IVD marked for in vitro diagnostic usage.The company plans to use the assay to detect HIV-1 Group M genomic mutations in protease, reverse transcriptase, and integrase regions from plasma in patients with HIV.
The Sentosa NGS workflow that the company's assay runs on enables automated RNA extraction, library construction, template preparation, sequencing, data analysis, and generation of both a pathology and a quality control report. Vela's workflow also allows clear sample traceability, as well as laboratory information system integration and connectivity.
The automated workflow processes clinical samples with as low as 1,000 copies per ml of HIV viral load, Vela said, adding the assay detects as low as 5 percent variant frequency at 4,000 copies per ml viral load. It has demonstrated 98.5 percent clinical sensitivity in all three target regions and 99.8 percent detection correctness, with 100 percent reproducibility.
Earlier this summer, Vela received regulatory approval for its Sentosa assay in Australia.