FDA Authorizes First Diagnostic Test for Screening of Asymptomatic People

COVID-19 Update: FDA Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection

Today, the U.S. Food and Drug Administration (FDA) reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use: testing people who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection, and pooled sample testing with up to five individual specimens. The FDA reissued the LabCorp COVID-19 RT-PCR Test EUA to expand 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. The reissuance also includes authorization for LabCorp to test pooled samples containing up to five individual swab specimens collected under observation. Sample pooling allows for fewer tests to be run overall, conserving resources and potentially allowing more tests to be evaluated quicker.

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