Singapore (July 14, 2017) – Vela Diagnostics announced today that the Australian Therapeutic Goods Administration (TGA) has approved its Next Generation Sequencing (NGS)-based Sentosa® SQ HIV Genotyping Assay for diagnostic use. The Sentosa® SQ HIV Genotyping Assay is intended for the detection of HIV-1 Group M genomic mutations in Protease, Reverse Transcriptase and Integrase regions from plasma in patients diagnosed with HIV infection. The assay is also currently being reviewed for Singapore Health Science Authority (HSA) and is pending CE-IVD approval.
The Sentosa® SQ HIV Genotyping Assay is validated on the highly automated Sentosa® NGS workflow which enables automated RNA extraction, library construction, template preparation, sequencing, data analysis and generation of both Pathology report and Quality Control report. The Sentosa® NGS workflow also allows clear sample traceability, with seamless LIS integration and connectivity.
The Sentosa® SQ HIV Genotyping Assay on Sentosa® NGS workflow is highly sensitive and delivers clinically relevant results with reduced hands on - and turn around time in comparison to Sanger and other non automated NGS alternatives. The automated workflow is validated to process clinical samples with as low as 1,000 copies/mL of HIV viral load. This highly sensitive assay is also able to detect as low as 5% variant frequency at 4000 copies/mL viral load, and has demonstrated 98.50% clinical sensitivity in all three target regions, 99.82% variant detection correctness, with 100% reproducibility.
To learn more about Sentosa® NGS workflow and test menu, visit http://www.veladx.com/products.html#ngs