Singapore (October 15, 2014) – Vela Diagnostics announced today the availability of the Sentosa^® SQ HCV Genotyping Assay for Next-Generation Sequencing (NGS)-based genotyping of hepatitis C virus (HCV) in plasma and serum for early access customers¹ for research use only. This is the second NGS panel to be launched by Vela Diagnostics, which recently launched the CE-IVD Sentosa^® SQ Melanoma Panel.

The Sentosa^® SQ HCV Genotyping Assay detects genotypes 1, 2, 3, 4, 5, and 6, and subtypes 1a and 1b by targeting NS5A and NS5B regions for broader subtype identification when compared to other commercially available tests. The Limit of Detection (LOD) of the Sentosa^® SQ HCV Genotyping Assay is determined to be 1000 IU/mL for genotypes 1a, 1b, 2, 3 and 4, and 2000 IU/mL for genotypes 5 and 6. The accuracy rate for the Sentosa^® SQ HCV Genotyping Assay is 100% for HCV genotype 1a, 1b, 2, 3, 4, 5 and 6 with 99.20% (95% CI: 97.20% – 99.79%) reproducibility.

The automated Sentosa^® NGS workflow supports DNA extraction, library preparation and comprehensive result reporting. The automated reporting allows rapid and accurate genotyping across the complex HCV genome that helps to reduce time and costs. The easy-to-interpret report format includes automated bioinformatics and results interpretation. The Sentosa^® NGS workflow also allows for seamless sample tracking and IT connectivity to ease information transfer and sample traceability.

Vela Diagnostics is the only provider to offer an automated workflow that supports both NGS and PCR tests²; currently 27 IVD PCR tests are available and 6 additional NGS panels are planned for launch. Both NGS and PCR workflows utilize the Sentosa^® SX101, a liquid handling platform that performs DNA extraction, PCR set-up and library preparation. The capability to share the components between PCR and NGS workflow increase the flexibility and efficiency of the workflow. The goal of a combined workflow and complementary tests is to provide the appropriate technologies for today’s growing complex laboratory needs with improved efficiency.