The FDA on Friday added two new indications for the use of a Laboratory Corporation of America (NYSE:LH) COVID-19 RT-PCR diagnostic: to test people who have no symptoms of the virus or have no reason to believe they’ve been exposed; and to allow pooled testing of up to five samples from different people.
The test, which received an emergency use authorization March 16, 2020, may now be used to screen people as they return to work and school. The company provided scientific data showing that the test is as accurate in the broader asymptomatic population as it is among people suspected to have COVID-19, according to the FDA.
Its authorization to be used in sample pooling will allow for fewer tests to be run overall, conserving testing supplies and personal protective equipment, and potentially allowing more samples to be evaluated quicker, the agency added. LabCorp is the second company to receive authorization for pooled sample testing. On July 20, the FDA permitted a Quest Diagnostics (NYSE:DGX) test for COVID-19 to be used with pooled samples.
“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 Hahn in a news release published today. “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 the FDA continues to work around the clock with test developers to support this goal.”
In June, the FDA posted updated templates with recommendations for test developers to demonstrate validation for a test to be authorized for screening of asymptomatic people, as well as for sample pooling.
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 healthcare provider. However, the FDA is only allowing healthcare provider-collected samples to be pooled at this time.
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. Friday’s authorization eliminates the need for a provider to consider risk factors such as exposure or community spread when prescribing this test. The FDA said it continues to work with test developers to expand access to COVID-19 testing.
