NC-based LabCorp’s at-home COVID-19 testing kit is first to get FDA approval

State - Regional

BURLINGTON, N.C. (WNCN) — North Carolina-based clinical laboratory company LabCorp’s recently developed at-home COVID-19 testing kit will be the first to receive approval from the U.S. Food and Drug Administration (FDA), the company announced Wednesday.

The Pixel by LabCorp COVID-19 Test Home Collection Kit was granted Emergency Use Authorization (EUA) and will become the first to be available over the counter without requiring a prescription. 

The company says the kit is currently available through the Pixel by LabCorp website, and this approval will enable LabCorp to potentially distribute the kit through retail channels.

“This authorization is the latest example of LabCorp’s commitment to increase access to COVID-19 testing,” the company said in a press release.

The kit allows consumers to self-collect their sample in the privacy of their own home, which helps minimize transmission of the virus. Users then send the sample for processing at LabCorp.

“With the first over-the-counter at-home collection kit ever authorized by the FDA for COVID-19, we are empowering people to learn about their health and make confident decisions,” said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics. “With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.”

Upon purchase, users register their Pixel by LabCorp COVID-19 collection kit at the Pixel by LabCorp website and follow the instructions included.

Test results are securely delivered to the consumer via the Pixel by LabCorp portal.

A healthcare provider will counsel consumers who test positive to assist with healthcare treatment and actions.

The Pixel by LabCorp COVID-19 collection kit is not a substitute for visits to a healthcare professional and is for use in adults 18 and older, the company said.

Retailers interested in selling Pixel by LabCorp COVID-19 collection kits can contact the company at PixelPartners@LabCorp.com.

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