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FDA Authorized Labcorp COVID Test to identify PANGO Lineages

6/14/22 — The FDA issued an emergency use authorization (EUA) 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 genetic variation in circulating virus strains, also called lineages. The Labcorp VirSeq SARS-CoV-2 NGS Test is: 

  • The first COVID-19 test authorized for the identification and differentiation of SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages.
  • A next-generation sequencing (NGS) based test authorized for testing patient respiratory samples (such as anterior nasal or nasopharyngeal swab samples) identified as SARS-CoV-2 positive using Labcorp’s COVID-19 RT-PCR Test and Labcorp SARS-CoV-2 & Influenza A/B Assay. 
  • Intended to be used when a healthcare provider decides, based on a patient’s medical history and other diagnostic information, that the test results may help in deciding the appropriate clinical care for the patient.
  • The test can be performed at certain laboratories designated by Labcorp that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that meet the requirements to perform high-complexity testing.