The FDA is warning users not to use Cue Health’s at-home Covid-19 tests

The US Food and Drug Administration (FDA) has warned users not to use Cue Health’s at-home Covid-19 tests, just a week after the agency issued a warning letter saying Cue was not following the conditions specified in the emergency use authorizations for its testing.

The FDA warning said the tests could produce false results, specifically saying the company had changed the way the electrochemical signals in the test device were generated, received and interpreted. These changes have not been approved by the FDA and, according to the agency, could reduce the stability of the tests and lead to false results.

San Diego-based Cue Health has suffered during the pandemic as demand for Covid-19 tests has declined. The workforce continues to be cut, with 714 layoffs in January and April 2023, 245 in January 2024 and 230 this month. The company went public in 2021 at a valuation of nearly $2.3 billion. However, according to the company’s financials, it lost $194.1 million and $373.5 million in 2022 and 2023, respectively.

The Cue Health Covid-19 Test for Home and Over-the-Counter Use was approved by the FDA for point-of-care testing in June 2020 and received Emergency Use Authorization (EUA) for at-home use in March 2021. Cue secured $481 million in a deal with the US government in October 2020 to ramp up production of the tests, which would reportedly be used by the NBA to screen players.

The Nucleic Acid Amplification Test (NAAT) diagnoses the disease by analyzing a lower nasal swab sample taken using the single-use Cue Sample Wand, which is passed through the reusable Cue Cartridge Reader. It then delivers the results to its smartphone app.

The FDA said Cue Health has 15 days to address “specific steps your company has taken to address the violations identified, as well as an explanation of how your company plans to prevent these violations, or similar violations, from occurring.” may occur again,” in the May 9 Warning Letter.

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The agency recommended that users retest with another FDA-approved Covid-19 test. Last week, iHealth Lab’s Covid-19/Flu A&B won the FDA EUA for those ages two and older. The 3-in-1 test kit aims to provide results in 15 minutes and is said to be one of the first over-the-counter rapid antigen tests for both Covid-19 and influenza strains A and B in the US.