On Friday evening, the FDA reissued an emergency use authorization (EUA) for LabCorp's COVID-19 RE-PCR Test that now allows for testing among those without any symptoms of COVID-19.
The agency also expanded the indication to allow for pooled sample testing – a technique of combining multiple samples into a single test, and then following up with individual tests should the group be positive. The platform may test up to five samples per pool, and 25 specimens per matrix.
LabCorp's test can still be conducted with samples collected via authorized home sample-collection kits when prescribed to an asymptomatic individual, the agency noted. However, pooled testing may only be conducted using provider-collected samples.
This follows an announcement from the agency one week prior that expanded Quest Diagnostics' Quest SARS-CoV-2 rRT-PCR test indication to include pooled sample testing of up to four samples. That test allows for self-collected nasal swab specimens using a home kit ordered by a healthcare provider.
WHY IT MATTERS
Asymptomatic spread has been a particular challenge throughout the response to COVID-19. LabCorp's test could provide a much-needed dose of certainty to employers, schools and other organizations deciding whether or not to return to physical operations.
Pooled testing, meanwhile, is a boon to public health agencies and testing labs that are finding themselves once again challenged by mounting COVID-19 cases. Although this testing approach is intended for use in areas with relatively low case prevalence, pooled testing can help labs more quickly churn through a backlog of testing samples while conserving manpower and resources.
“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 Dr. Stephen M. 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. 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.”
THE LARGER TREND
COVID-19 testing capability in the U.S. has been inconsistent since the early days of the pandemic. Although the FDA has steadily provided EUAs to a growing number and range of tests – including those for the first antibody-based test in early April and a saliva-based home sample collection platform in May – both LabCorp and Quest Diagnostics have recently said that they were facing difficulties keeping up with testing demand in hard-hit areas of the country.