FDA authorizes first at-home COVID-19 test available without a prescription

After 10 months and nearly 200 different authorized COVID-19 tests, the FDA has greenlit its first at-home coronavirus diagnostic available directly to the consumer without a prescription. (LabCorp)

No search for an open COVID-19 testing center. No waiting in line. No need to even venture outside the house, in fact. That's the promise of LabCorp's Pixel test, which has secured an FDA green light for home delivery without a prescription.

LabCorp's home-testing push is one of the biggest in the industry, alongside sample collection kits from Everlywell and Quest Diagnostics, with the latter receiving a federal authorization earlier this week for a kit that tests for both COVID-19 and the flu. However, both require a note from a physician.

The FDA first authorized the Pixel test in late April. Now, the self-collection kit can be purchased directly through LabCorp’s website by anyone age 18 and older—for $119 out-of-pocket, though the full price can be covered by public and private health insurance. 

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After swabbing the inside of the nose, the sealed sample is then shipped overnight in a prepaid FedEx envelope to a laboratory for analysis, with results turned around within one to two days on average.

“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 release. “With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.”

LabCorp’s online portal will also connect users who test positive with a healthcare provider, to assist with isolation and treatment. The company also plans to stock the test kit at nationwide retailers.

“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,” said Jeff Shuren, director of the FDA’s device center.

RELATED: LabCorp to launch single home swab test spanning COVID-19, flu, RSV

This month, LabCorp said it has seen a nationwide rise in demand for COVID-19 testing, as the number of new daily cases continues to set grim records. Currently, the company is performing more than 1 million molecular tests per week, with a capacity of 270,000 per day at 21 labs to help diagnose active infections.

That demand is expected to increase further over the coming weeks. LabCorp said its current average time to process a sample and return a result is between 24 and 48 hours.