FDA authorizes first COVID-19 diagnostic test for screening asymptomatic people

Editor's Note

The Food and Drug Administration (FDA) on July 24 reissued its emergency use authorization (EUA) for LabCorp’s COVID-19 RT-PCR Test to include two new indications for use:

• Testing for individuals who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection.
• Allowing for pooled sample testing with up to five individual specimens.

The FDA previously issued an EUA of the test for those with suspected COVID-19 and individual specimens.

“The FDA’s authorization of the first diagnostic test to be used for anyone, regardless of whether they are showing symptoms of COVID-19 or have other exposure risk factors, is a step toward the type of broad screening that may help enable the reopening of schools and workplaces,” says FDA Commissioner Stephen M. Hahn, MD.