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LabCorp Receives EUA for OTC COVID-19 Molecular Test Home Collection Kit

NEW YORK – Laboratory Corporation of America said on Wednesday that it has received US Food and Drug Administration Emergency Use Authorization for an over-the-counter version of its Pixel by LabCorp COVID-19 Test Home Collection Kit.

With the EUA, LabCorp is able to sell the test kit directly to consumers without requiring a prescription. The kit is currently available through the Pixel by LabCorp website and the company said it may also distribute it through retail channels.

The kit is the first over-the-counter at-home collection kit for SARS-CoV-2 to receive EUA.

Users can self-collect nasal swab samples and send them in for processing at LabCorp, which will run the samples on its COVID-19 PCR test. Healthcare providers will deliver positive or invalid results to patients, while negative results will be delivered by email or online portal.

"This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription," Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement. "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."

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