NEW YORK (GenomeWeb) – Vela Diagnostics announced today that it its next-generation sequencing-based hepatitis C genotyping assay has received CE marking, clearing the test for in vitro diagnostic use in Europe.
The Sentosa SQ HCV genotyping assay covers clinically relevant regions of NS3, NS5A, and NS5B and detects genotypes 1 through 6, as well as subtypes 1a and 1b, according to the company. It runs on the company's highly automated Sentosa NGS platform.
The HCV assay was approved for diagnostic use in Australia last month.
Last year the firm launched its CE-marked Sentosa SQ Thyroid Cancer Panel, a next-gen sequencing-based assay that simultaneously detects 105 hot spots in 10 genes associated with thyroid cancer.