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December 10, 2020

FDA authorizes first over-the-counter COVID-19 test for at-home use

LapCorp's Pixel diagnostic allows people to conduct their own nasal swab and return the sample for processing

Health News Coronavirus
Pixel COVID-19 test Courtesy of/LabCorp

The Pixel COVID-19 test allows people to collect a nasal swab at home and send the sample to LabCorp for processing.

An at-home coronavirus test that does not require a prescription is now available to any adult needing a test. 

The U.S. Food and Drug Administration issued an emergency use authorization Wednesday for the first over-the-counter, at-home COVID-19 test, a move that will help expand testing capacity.

LATEST: FDA authorizes Pfizer's COVID-19 vaccine

The test, named Pixel, was developed by LabCorp and can be self-administered at home by anyone ages 18 and older. After collecting a nasal swab, people must send their test sample to LabCorp for processing. 

Positive or invalid results are delivered by phone from a health care provider. Negative results are sent via email or through LabCorp's 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," Dr. Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health said in a statement

LabCorp's COVID-19 testing kit is currently available online where consumers can elect to bill their insurer or pay its $119 price out of pocket. People without health insurance may be eligible to receive the test through federal funding. The test also will soon become available in stores.

"With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities," said Dr. Brian Caveney, LabCorp’s chief medical officer.

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