Coronavirus: FDA authorizes first over-the-counter at-home COVID-19 test system

The U.S. Food and Drug Administration granted an emergency use authorization on Wednesday for the first nonprescription, over-the-counter COVID-19 test kit for at-home use.

In a news release, the FDA announced the LabCorp Pixel COVID-19 Test Home Collection Kit will be available for purchase to anyone 18 or older.

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“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,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the release.

According to CNN, positive or invalid test results will be delivered back to the consumer via phone or through a health care provider, while negative test results will be communicated via email or through an online portal.

“With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities,” Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics, said in a prepared statement.

Read more here and here.

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Cox Media Group