By Vela Diagnostics

Genomeweb/ Singapore (May 3, 2016) – Vela Diagnostics announced today 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 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. 

An estimated 150 to 200 million people worldwide are infected with Hepatitis C. The virus persists in the liver in about 85% of the population infected with Hepatitis C. This chronic infection can be treated with medication. Overall, 50% to 90% of people treated can be cured. No vaccine is currently available for Hepatitis C. Genotyping information is required before initiation of therapy since the treatment regimen is typically selected based on the presence of a specific genotype and is therefore relevant for the management of HCV infected patients.  Both the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) have issued clinical guidelines on genotype specific treatment regimen. 

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.  If interested to enroll or to learn more, please contact gpm@veladx.com.

To learn more about Sentosa® NGS workflow and test menu, visit http://www.veladx.com/products.html#ngs