NEW YORK – The US Food and Drug Administration announced after the close of the markets on Friday that it has issued Emergency Use Authorization (EUA) for Laboratory Corporation of America's VirSeq SARS-CoV-2 NGS Test.
The test uses the PacBio Sequel II NGS system and is intended to identify specific SARS-CoV-2 strains in patient samples identified as SARS-CoV-2 positive using Labcorp’s COVID-19 RT-PCR Test or its SARS-CoV-2 & Influenza A/B Assay when a healthcare provider believes that strain-specific information could help guide appropriate patient care. The test, the FDA said in its authorization letter, is not to aid in the primary diagnosis of SARS-CoV-2 infection or to confirm the presence of infection with the virus. Nor is it to identify specific SARS-CoV-2 genomic mutations.
The test, which uses respiratory samples, is the first to receive FDA EUA for identification and differentiation of SARS-CoV-2 strains. It can be performed at Labcorp laboratories designated under CLIA as meeting the requirements to perform high-complexity testing.