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Labcorp Receives FDA EUA for Combo COVID-19/Flu Home Collection Kit

NEW YORK – Laboratory Corporation of America said on Friday that it has received Emergency Use Authorization from the US Food and Drug Administration for a combined home collection kit for molecular testing for COVID-19 and influenza A/B.

The kit is intended for use in individuals 2 years of age and older and is available at no upfront cost to those who meet clinical guidelines, which include individuals experiencing symptoms, those who have been exposed to someone with COVID-19, or those who have been recommended for testing by a healthcare provider.

The collection kit uses the Roche Cobas SARS-CoV-2 & Influenza A/B Test for use on the Cobas 6800/8800 Systems for testing nasal or nasopharyngeal samples. The Cobas SARS-CoV-2 & Influenza A/B Test is an RT-PCR assay that simultaneously and qualitatively detects and differentiates the SARS-CoV-2, influenza A, and influenza B viruses.

The kit will become available in early October and can be ordered either through Pixel by Labcorp or by an individual's physician.

"Our newest home collection kit makes it convenient for individuals, including children over the age of 2, to take the test in the safety of their homes," Brian Caveney, chief medical officer and president of Labcorp Diagnostics, said in a statement. "In time for flu season, the single test helps doctors and individuals make more informed treatment decisions given that symptoms of COVID-19 and flu are similar."