NEW YORK (GenomeWeb) – Vela Diagnostics has received approval from the Singapore Health Sciences Authority for in vitro diagnostic use of its Sentosa SQ HIV Genotyping Assay.
The next generation sequencing-based panel also attained CE-IVD status and approval from the Therapeutic Goods Administration in Australia earlier this year.
The assay detects HIV-1 Group M genomic mutations in protease, reverse transcriptase, and integrase regions of the virus using plasma from patients diagnosed with HIV infection. Resistance of HIV to antiretroviral drugs is the most common cause for therapeutic failure — detection of resistance mutations is critical for optimal selection of an antiretroviral therapy regimen and can also combat the development of resistance to antiviral drugs, Vela noted.Â
The assay runs on Vela's Sentosa NGS workflow — automated RNA extraction, library construction, template preparation, sequencing, data analysis, and generation of both pathology and quality control reports — which is validated to process clinical samples with as low as 1,000 copies per mL of HIV viral load. The assay is able to detect 5 percent variant frequency at 4,000 copies per mL of viral load, and has demonstrated 98.5 percent clinical sensitivity in all three target regions, 99.8 percent variant detection correctness, with 100 percent reproducibility, the firm added.