Labcorp NGS Test for Identifying SARS-CoV-2 Strains Receives FDA EUA

Original from: 360DX

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.

Source: Labcorp NGS Test for Identifying SARS-CoV-2 Strains Receives FDA EUA