First direct-to-consumer coronavirus test gets FDA authorization

Posted at 9:12 PM, Dec 09, 2020

For the first time, the FDA has authorized coronavirus tests that can be sold directly to Americans who do not have to go through a health care provider.

An emergency use authorization is not a full approval from the FDA, but allows the tests to be used in a non-clinical or non-hospital setting.

The LabCorp’s Pixel COVID-19 Test Home Collection Kit can be used by any adult age 18 or over. The test kit allows individuals to take a nasal swab at home and send the sample to LabCorp for testing.

Those who test positive will receive a call from a health care provider. Negative tests are delivered via an online portal or through email.

The FDA says that the tests can be purchased online or in stores, and can help people determine whether they need to quarantine.

“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,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “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.”

The company says the out of pocket cost is $119 for those who do not have the test covered by insurance. The tests take one to two days to process, once received via FedEx.

“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.”