LabCorp Wins Reissued EUA for COVID-19 Test, First to Test Asymptomatic Population

By MedTech Intelligence Staff

The authorization is a step toward broad screening that will help reopen schools and workplaces in America, says FDA Commissioner Stephen Hahn, M.D.

LabCorp’s COVID-19 RT-PCR Test has received another emergency use authorization (EUA) for two additional indications for use: Testing asymptomatic patients for COVID-19 and for pooled sample testing (pooled samples with up to five swab specimens). The authorization for expanded use was issued following review of scientific data showing that the test could detect SARS-CoV-2 in asymptomatic patients. The test received the initial EUA on March 16 for patients suspected of having COVID-19, and for testing individual specimens (not sample pooling).

“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. 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.” – FDA Commissioner Stephen M. Hahn, M.D.

The LabCorp test is only available with a prescription. It is authorized for use in the home using a sample collection kit (Pixel by LabCorp or other specific home sample collection kit) or by a healthcare provider.

Related Articles

About The Author

MedTech Intelligence