FDA authorizes first at-home COVID-19 diagnostic test sampling without prescription

The Food and Drug Administration yesterday authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by adults without a prescription. FDA revised and reissued the emergency use authorization for the test to allow an individual to collect a nasal swab sample at home and send it to LabCorp for testing, with positive or invalid results delivered by a health care provider by phone and negative results delivered via email or online portal.

“While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing,” said Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health.