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FDA Issues First EUA for SARS-CoV-2 Diagnostic Testing Intended to Test Asymptomatic Individuals

FDA maze of regulations

New EUA opens the door for increased availability of COVID-19 testing for asymptomatic individuals.

The US Food and Drug Administration (FDA) announced July 24, 2020, that an emergency use authorization (EUA) has been reissued for a previous SARS-CoV-2 RT-PCR test. This reissued EUA is for the LabCorp COVID-19 RT-PCR Test. The EUA extends the scope of the test to allow testing on asymptomatic individuals and to permit pooled testing for up to five samples. 

The reissued EUA is the first EUA to explicitly allow testing specifically for asymptomatic individuals. The LabCorp EUA is also the second test authorized to perform pooled testing. While there is one other EUA that permits pooled SARS-CoV-2 diagnostic tests, issued July 18, 2020, the LabCorp EUA allows for up to five pooled specimens, instead of four.

“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 M. Hahn, MD, in a press release. “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 FDA notes: The LabCorp test remains prescription-only and is authorized for human specimen collection either at home using the Pixel by LabCorp or other home sample collection kits authorized for use with LabCorp’s test, or by a health care provider. However, only health care provider-collected samples may be pooled at this time. Additionally, the data reviewed by the FDA demonstrated that the test is as accurate in the broader asymptomatic population as it is among people suspected to have COVID-19.”

Related Resources:

LabCorp COVID-19 RT-PCR Test EUA

FDA Press Release: FDA Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection