FDA Authorizes First COVID-19 Test to Identify Specific SARS-CoV-2 Lineages

The U.S. Food and Drug Administration (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 health care 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.