FDA issues EUA for Labcorp NGS test to detect SARS-CoV-2 strains

2021 01 11 17 03 4617 Covid Diagnostic Test Kit 400

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.

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