FDA authorizes first COVID-19 diagnostic test for asymptomatic people
The Food and Drug Administration Friday reissued its emergency use authorization for the LabCorp COVID-19 RT-PCR Test to include authorized use for asymptomatic individuals and for pooled sample testing with up to five individual specimens. FDA previously authorized emergency use of the test for patients with suspected COVID-19 and individual specimens.
“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,” said FDA Commissioner Stephen Hahn, M.D. “By authorizing another test for use with pooled samples, we also further help increase the possibility that patients may be able to receive results sooner, while also conserving vital testing supplies, which are under increased demand during the pandemic.”