FDA Authorizes First Test For Consumer At-Home Sample Collection For COVID-19

The U.S. Food and Drug Administration authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by consumers at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.

This reissued EUA for LabCorp’s molecular test permits testing of a sample collected from the individual's nose using a designated self-collection kit that contains nasal swabs and saline. Once individuals self-swab . . .