Cue Health’s Covid-19 tests lead to false results, FDA warns

The Food and Drug Administration warned consumers Monday to not use Cue Health’s at-home Covid-19 tests. This follows an FDA warning letter to the company last week that said Cue was not following the conditions stipulated in the emergency use authorizations for its tests.

The FDA letters said the tests could give false results. Specifically, the agency said that the company had changed how the electrochemical signals within the test device were generated, received, and interpreted — changes the FDA has not authorized. These changes decreased the stability of the tests and might lead to false results, the agency said.

The FDA warnings come near what might be the end of a spectacularly bumpy ride for the company. When Cue went public in 2021, it was valued at nearly $3 billion. It supplied tests for the NBA’s 2020 “bubble,” leading a Trump administration official to proclaim that if the test was “good enough for LeBron,” the administration would bring it to the American people — and it did, in a $481 million deal.

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