Singapore-based Vela Diagnostics has secured the CE Mark for its next-generation sequencing (NGS) based Sentosa SQ HCV Genotyping Assay for in-vitro diagnostic hepatitis C treatment.
The assay is approved for viral genotyping of 1, 2, 3, 4, 5, and 6, and subtypes 1a and 1b in patients diagnosed with hepatitis C Virus infection from human plasma or serum sample.
It covers clinically relevant regions of NS3, NS5A and NS5B and has exhibited 100% clinical sensitivity and 99.39% clinical genotyping accuracy.
The assay operates on the highly automated Sentosa NGS workflow, which results in the delivery of a series of functions such as RNA extraction, library construction, template preparation, sequencing, data analysis and generation. These are then available in reports into both pathology and quality control (QC).
The QC reports offer complete QC information, while the one on pathology states the detected variants in the patient, and provides automated reporting.
Sentosa NGS workflow promotes clarity in sample traceability, with seamless laboratory information system (LIS) integration and connectivity.
Hepatitis C is a chronic medical condition where the virus is based in the liver in 85% of those infected.
Genotyping information is necessary prior to a therapy as it is selected on the basis of a specific genotype and is relevant for the management of HCV infected patients.
Vela Diagnostics provides automated platforms to support both NGS and PCR workflows, which share the Sentosa SX 101 automatic pipetting system, resulting in enhanced efficiency and flexibility.