Media Statement: Labcorp receives FDA Emergency Use Authorization for first COVID-19 test to identify specific SARS-CoV-2 lineages

BURLINGTON, N.C.,  June 14, 2022 — On Friday, June 10, 2022, Labcorp, a global life sciences company, received an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its VirSeq SARS-CoV-2 NGS (next-generation sequencing) Test on the PacBio Sequel II sequencing system. This is the first test authorized for the identification and differentiation of SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages, which are genetic variations in circulating virus strains.

VirSeq SARS-CoV-2 NGS Test can identify specific SARS-CoV-2 strains in patient samples. The test could be used by health care providers if they believe, based on a patient medical history and other diagnostic information, that strain-specific information could help determine appropriate patient treatment. The test is not intended to be used in a primary diagnosis of SARS-CoV-2 infection, to confirm the presence of infection, or for identification of specific SARS-CoV-2 genomic mutations.

The FDA EUA for VirSeq SARS-CoV-2 NGS Test is another example of Labcorp’s ability to respond quickly during the pandemic and it underscores the strength of our scientists, the value of our technology and our focus on innovation.