Telehealth Startups Pause At-Home COVID-19 Testing After FDA Tightens Guidelines

The Food and Drug Administration is cracking down on at-home testing for COVID-19 after several telehealth startups announced plans to introduce the service.

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The FDA released a statement on Friday that it was monitoring the market for COVID-19 tests, and had become aware of “unauthorized fraudulent test kits” that were being advertised for home testing. In a “Frequently Asked Questions” post published on Saturday, the FDA clarified that its guidance for testing didn’t apply to at-home tests.

“At this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19,” Friday’s statement read. “The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space.”

Nurx, Carbon Health and EverlyWell were among the startups that announced they were rolling out at-home testing for COVID-19. Given the new information from the FDA, Nurx and Carbon Health have stopped distributing the tests. EverlyWell said Sunday that it would be allocating tests to hospitals and health care companies with workers on the frontline.

Before March 21, Nurx’s longtime lab partner, Molecular Testing Labs, was conducting its COVID-19 at-home collection test validation in accordance with the FDA’s Emergency Use Authorization guidance issued on Feb. 29, the company said in a statement. But on March 21, the FDA said its earlier guidance didn’t apply to at-home, self-collection of specimens for lab testing for COVID-19.

“Given new guidance from the FDA specific to self-collection laboratory testing on March 21, Nurx and Molecular have made the responsible decision to pause on providing any additional self-collection COVID-19 tests,” the company said. “Molecular is in direct communication with the FDA regarding this most recent guidance and they continue to have high confidence in the test characteristics and accuracy of its self-collection COVID-19 test.”

Carbon Health released a statement saying the company was notified by its lab partner, Curative Inc., that the FDA’s Saturday COVID-19 testing update “clarified that at-home sample collection is not covered under the emergency use authorization.”

“Carbon Health is discontinuing distribution of the at-home sample collection kits effective immediately,” CEO Eren Bali said in a statement. “We are also contacting our 50 initial patients to schedule expedited testing in our clinics. No patients had received results yet.”

Illustration: Dom Guzman