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FDA Reissues EUA for LabCorp Molecular SARS-CoV-2 Test for Asymptomatic Population, Pooled Testing

NEW YORK ­– The US Food and Drug Administration said Friday evening that it has reissued an Emergency Use Authorization for Laboratory Corporation of America's COVID-19 RT-PCR Test for testing the broad population, even if they are asymptomatic, and for pooled testing for SARS-CoV-2, the virus that causes COVID-19.

The FDA reissued the EUA for the new uses after LabCorp provided data showing the test could detect SARS-CoV-2 in a general asymptomatic population, the agency said. LabCorp originally received EUA for the test in March.

The FDA noted that until now molecular tests for detecting SARS-CoV-2 have been available only with a prescription by a healthcare provider to patients suspected of having the coronavirus, and to asymptomatic patients at the discretion of a healthcare provider. The new authorization "eliminates the need for a provider to consider risk factors such as exposure or community spread when prescribing this test," the FDA said in a statement.

For pooled testing with the LabCorp COVID-19 RT-PCR Test, five individual swab specimens may be collected under observation. Pooled testing is an established method for the screening and surveillance of a variety of infectious diseases, but the FDA issued its first EUA for a test for the approach only last week to Quest Diagnostics. Use of the method for COVID-19 testing has taken on greater urgency as lab testing capacity has become an issue again with the recent spike in COVID-19 cases in parts of the US. With a second wave of coronavirus cases anticipated in the fall, combined with the flu season, many are worried about supply shortages and labs' ability to meet SARS-CoV-2 testing demands. 

Pooled sampling, which allows samples from multiple individuals to be tested simultaneously using one test, can save resources and accelerate the testing process.

"Pooled testing may be used for populations at low risk of COVID-19, when testing demand exceeds laboratory capacity, or when testing reagents are in short supply," LabCorp said on Saturday in a separate statement.

The FDA provided guidance on pooled samples in June.

"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," FDA Commissioner Stephen Hahn said in a statement. "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."

The LabCorp test is authorized for human specimen collection at home using the Pixel by LabCorp or other home sample collection kits authorized for use with LabCorp's test, or by a healthcare provider. However, only samples collected by healthcare providers may be pooled using the test, the FDA said.