The US FDA has revoked the Emergency Use Authorization (EUA) for Cue Health’s two Covid-19 tests and has classified the formerly voluntary recall of the two tests as Class II.
The two tests in question are the Cue COVID-19 Test and the Cue COVID-19 Test for home and over-the-counter (OTC) use. The Class II recall follows the warning letter the US agency sent back in May. The letter advised customers against using the at-home Covid-19 test.
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The warning was issued after the FDA’s inspection of Cue Health’s operation found that the company had made unauthorised changes to the test that undermined the test’s reliability in detecting the SARS-CoV-2 virus. The agency first issued the EUAs to Cue Health for COVID-19 tests for detecting genetic material from SARS-CoV-2 virus in the nose in a point of care setting in 2020. The FDA expanded the test label to include home and OTC use in March 2021.
A Class II recall is issued by the FDA when it deems a product use “may cause a temporary or medically reversible adverse health consequence, or where the probability of serious adverse health consequences is remote”.
Cue Health filed for Chapter 7 bankruptcy on 28 May, just days after the FDA issued the warning letter. In a May SEC filing, the company noted that it had laid off all of its employees and executive officers as of 24 May.
The filing also stated that it had received a delisting warning from the Nasdaq Stock Market for failing to satisfy the listing requirement of maintaining the minimum bid price of $1 per share. Before this Cue Health had a valuation of around $2.3bn, with a public common stock price of $16 per share, when it went public in 2021.
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By GlobalDataCue Health is not the only company to suffer financial setbacks due to a decline in the demand for Covid-19 products. In July, Abbott reported a 38.8% decline in Covid-19 testing-related sales in the second quarter of 2024 (Q2 2024). The sales fell to $102m in Q2 2024 from $263m in the same quarter of the previous year. Abbott reported a 5.9% increase on an organic basis in global diagnostics sales when excluding the sales of Covid-19 tests.
Whilst Covid-19 tests formed the bulk of Cue Health’s pipeline, the company has developed a molecular test to detect the mpox virus. It received an EUA from the FDA for its Cue Mpox molecular test in March.
