The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization for the Laboratory Corporation of America (Labcorp) VirSeq SARS-CoV-2 NGS test on the PacBio Sequel II sequencing system.
The SARS-CoV-2 virus has mutated over time, resulting in multiple strains, also known as lineages.
According to the FDA, the Labcorp VirSeq SARS-CoV-2 NGS Test is the first COVID-19 test to identify and differentiate SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages. It is authorized for testing patient respiratory samples identified as SARS-CoV-2 positive using the Labcorp COVID-19 RT-PCR Test and Labcorp SARS-CoV-2 Influenza A/B Assay.
The NGS test can be performed in laboratories designated by Labcorp that are certified under CLIA, meeting requirements to perform high-complexity testing. Test results may help providers decide on appropriate clinical treatment for patients, the FDA added.