Dr. Stephen Hahn, commissioner of food and drugs at the U.S. Food and Drug Administration (FDA), speaks during a Senate Health, Education, Labor and Pensions Committee hearing in Washington, DC, on June 30.
Al Drago/Pool/Abaca/Sipa USA
The US Food and Drug Administration has authorized the first coronavirus test for asymptomatic Covid-19 cases and for those who don’t think they’re infected with the virus at all.
The agency reissued an emergency use authorization for a LabCorp Covid-19 RT-PCR test after the company provided scientific proof that the test was able to detect the virus in asymptomatic people. RT-PCR tests amplify genetic matter from the virus so it’s detectable.
The emergency use authorization also allows the test to be used on pooled samples.
“Today’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 in a statement.
The test could be a game changer for hospitals, businesses, schools and others, the FDA said.
“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 Hahn said in a statement Friday.
The FDA’s emergency use authorization for the LabCorp test also allows the company to test pooled samples of up to five individual swabs at a time to help test more samples using fewer testing supplies, which are in high demand and short supply in some areas.
“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,” Hahn said.
The test is only available through a prescription, the FDA said, and is only authorized for sample collection with LabCorp’s test kits or by a health provider.
The test first received an emergency use authorization in mid-March for testing only on people suspected of having Covid-19 and was not authorized for pool testing.