Updated on 17 May 2016
Singapore-based Vela Diagnostics announced that the Australian Therapeutic Goods Administration (TGA) has approved its Next Generation Sequencing (NGS)-based Sentosa SQ HCV Genotyping Assay for diagnostic use.
The Sentosa SQ HCV Genotyping Assay is intended for viral genotyping in patients diagnosed with Hepatitis C Virus infection from human plasma or serum sample. The assay is also currently being reviewed for CE-IVD and HSA approval.
The press release said that the Sentosa SQ HCV Genotyping Assay covers clinically relevant regions of NS3, NS5A and NS5B and detects genotypes 1, 2, 3, 4, 5, and 6, and subtypes 1a and 1b. The limit of detection is 1000 IU/mL for genotypes 1 (including 1a, 1b and others), 2, 3 and 4, and 2000 IU/mL for genotypes 5 and 6. The assay has demonstrated 100% clinical sensitivity and 99.39% clinical genotyping correctness.
The Sentosa SQ HCV 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.
Vela Diagnostics also announced that Sentosa SQ HIV Genotyping Assay is expected to be launched in June 2016. The early access program is now available.