First COVID-19 Diagnostic Test Approved for Everyone

July 26, 2020
John Parkinson

FDA reissues LabCorp’s existing diagnostic test for EUA, which opens up testing protocol for anyone.

The US Food and Drug Administration (FDA) has given the go-ahead to allow an existing COVID-19 diagnostic test be indicated for everyone.

On Friday, the FDA reissued LabCorp’s COVID-19 RT-PCR Test for emergency use authorization (EUA) to indicate it for use to test people who do not have coronavirus 2019 (COVID-19) symptoms or who have no reason to suspect infection.

This makes it the very first COVID-19 diagnostic test with this indication.

LabCorp was given the nod by the federal agency to expand use of its test to anyone, after the company provided data showing the test’s ability to detect SARS-CoV-2 in a general, asymptomatic population.

“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, MD, said.

Whereas, diagnostic tests have generally been authorized for people suspected of having COVID-19 by their provider, the FDA’s authorization eliminates the need for a provider to consider risk factors such as exposure or community spread when prescribing this test.

LabCorp’s test was originally issued an EUA on March 16 for use only in people suspected of being ill with COVID-19 by their health care provider and for testing of individual specimens without sample pooling.

In this most recent EUA, LabCorp was also given the authorization to indicate their COVID-19 RT-PCR Test for pool testing.

“We believe science and technology are the best ways to beat the virus, and our matrixed pooled testing method is another way LabCorp is helping to respond to this health crisis,” Brian Caveney, chief medical officer and president, LabCorp Diagnostics, said. “Pooling methods test groups of individuals efficiently and with high quality, while increasing our overall testing capacity. The demand for testing continues to increase and we are committed to finding innovative solutions to ensure testing is available.”

LabCorp’s matrixed pooled testing method involves testing up to five samples at once. If there is a positive sample in the pool, LabCorp can identify the individual positive sample in the pool using patterns detected by its robotic testing platform. Pooled testing can reduce the number of tests required in specific populations, optimize laboratory testing supplies, and increase testing capacity.