One of LabCorp’s newest indications will allow it to use its COVID-19 RT-PCR diagnostic to test for people who don’t have COVID-19 symptoms or who have no reason to suspect COVID-19 infection.
The Burlington, NC-based company also received an indication to have pooled sample testing.
Until now, molecular diagnostic tests have generally been authorized for people suspected of having COVID-19 by their healthcare provider, which has allowed asymptomatic people to be tested, when warranted, at the discretion of the healthcare provider. The federal agency said the authorization eliminates the need for a provider to consider risk factors such as exposure or community spread when prescribing this test.
FDA said it reissued the LabCorp COVID-19 RT-PCR Test EUA to expand the use of the test to anyone after the company provided scientific data showing the test’s ability to detect SARS-CoV-2 in a general, asymptomatic population. LabCorp has had EUA for its SARS-CoV-2 tests since March.
The measure is part of FDA’s move toward having broader screening.
“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. “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. Continuing to facilitate increased access to accurate and reliable tests for all Americans is critically important and FDA continues to work around the clock with test developers to support this goal.”
LabCorp’s test is the second diagnostic FDA authorized for pooled sampling. The agency first gave the designation to Quest Diagnostics.