Labcorp COVID-19 Test That Can Identify Viral Strains Gets EUA

The FDA has granted Emergency Use Authorization (EUA) to Laboratory Corporation of America’s Labcorp VirSeq SARS-CoV-2 next-generation sequencing test, which can differentiate between different strains of the virus that causes COVID-19.

The test analyzes positive samples identified using the company’s COVID-19 real-time polymerase chain reaction test, or its SARS-CoV-2 & Influenza A/B assay.

The test is intended to be used in conjunction with patient history and other diagnostic information, but it is not intended as an aid in the primary diagnosis of infection with SARS-CoV-2 or to confirm the presence of SARS-CoV-2 infection.

Results are not to be used as the sole basis for treatment or other patient management decisions, the FDA said.