Vela Diagnostics adds two SARS-CoV-2 assays for virus genotyping, and variant identification to its COVID-19 testing solutions

Vela Diagnostics announced that it has added ViroKey™ SQ FLEX SARS-CoV-2 Genotyping Assay and ViroKey™ SARS-CoV-2 ID RT-PCR Test to its portfolio offering.

The ViroKey™ SQ FLEX SARS-CoV-2 Genotyping Assay (RUO) harnesses next-generation sequencing (NGS) technology to sequence the whole SARS-CoV-2 genome. The accompanying Sentosa™ SQ Reporter software calls out mutations and classifies them by lineage, thereby aiding in the research and understanding of the molecular epidemiology of the COVID-19 pandemic. According to WHO, whole genome sequencing is essential for improving effectiveness/sensitivity of molecular diagnostics, serological assays, vaccine design and anti-viral therapy, and aiding investigation of transmission routes and outbreak clusters.

"We offer a highly automated workflow which requires less than 2 hours of hands-on time from sample to report generation. With this ease-of-use, laboratories can very quickly adopt an NGS solution that would become an important tool in this pandemic situation," said Managing Director, Andreas Goertz.

The ViroKey™ SARS-CoV-2 ID RT-PCR Test (RUO) is able to quickly identify variants present in positive samples. Variants include the B.1.1.7 (UK), B.1.351 (South Africa) and P.1 (Brazil) lineages.

"Identification of variants that may cause more severe disease or be more contagious is critical in our global response to the pandemic. Such variants may lead to more cases of COVID-19, putting strain on healthcare systems and potentially leading to more deaths. As such, they need to be identified promptly for measures to be taken," says Vice President, Jim Mismas.

"With emerging variants, like the recent B.1.526 from New York, that may weaken vaccine effectiveness, the need for mutation identification becomes clear. We are now able to offer options for quick detection of known variants of concerns, and all future variants for better pandemic management," says Director of Business Development, Scott Cassidy.

The variant identification test can be used in conjunction with the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0, which has received FDA Emergency Use Authorization, CE-IVD and TGA approval, and HSA Provisional Authorization.

About Vela Diagnostics

Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA's test solutions utilize the automated Sentosa™ platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.