20th June 2016 Content supplied by: Vela Diagnostics
Vela Achieves CE-IVD Marking for HCV Genotyping NGS Assay
Vela Diagnostics have announced their Next-Generation Sequencing (NGS)-based Sentosa® SQ HCV Genotyping Assay is now CE marked for in-vitro diagnostic use. It has been certified to meet the requirements for EC Directive 98/79/EC Annex IV for the high-risk IVD products. The Sentosa® SQ HCV Genotyping Assay is approved for viral genotyping in patients diagnosed with Hepatitis C Virus infection from human plasma or serum sample. It is the first commercially available NGS assay to be approved for high-risk blood disease.
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 QC report generated provides comprehensive QC information while the Pathology report summarizes the detected variants in the patient, and provides automated reporting. 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 offers automated platforms that support both NGS and PCR workflows. The workflows share the Sentosa® SX 101 automatic pipetting system thereby increasing efficiency and flexibility. Currently Vela Diagnostics offers 28 PCR tests (24 CE-IVD and 21 TGA approved), 5 NGS panels (5 CE-IVD and 5 TGA approved), 19 different sample types and open-channel capabilities.
Date Published: 20th June 2016
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