FDA cracks down on telehealth startups' at-home COVID-19 tests

After multiple telehealth startups began marketing direct-to-consumer coronavirus testing kits, the FDA has issued an alert noting that is has not authorized any such tests, which may "pose serious health risks."

Among the startups offering these tests were Nurx and Carbon Health, both of which ceased distribution of their tests after the FDA issued its alert on March 20, The New York Times reports.

These and other startups gathered samples via throat swabs, inner-cheek swabs or saliva samples, which they claimed produced results nearly as accurate as CDC-recommended nasopharyngeal samples. Public health experts and the FDA, however, were not convinced.

"That sounds to me like a really terrible idea," Sheldon Campbell, MD, PhD, associate director of the Yale School of Medicine's Clinical Microbiology Laboratory, told NYT. "There is concern, in this outbreak emergency setting, that good labs will cut corners and that bad labs will spring up to exploit the opportunity to make a quick buck."

Health experts and regulators also took issue with the startups' claims that the at-home samples were being tested in accredited labs that had received emergency authorization from the FDA. The agency reportedly said in a notice that the authorization does not apply to samples gathered at home and sent to an accredited lab.

"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," read the FDA's March 20 alert, which continued, "Fraudulent health claims, tests, and products can pose serious health risks. They may keep some patients from seeking care or delay necessary medical treatment. The FDA reminds consumers to follow [CDC] guidelines and speak to your medical provider if you have symptoms of COVID-19."


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