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FDA Warns: Government-Funded COVID-19 Test Not On Cue

 
• By Elizabeth Orr

The US FDA is warning against the use of Cue Health’s COVID-19 test, which was developed and manufactured with $481m of government funding. A recent inspection found unauthorized alterations to the product.

Cue Health's COVID-19 OTC molecular test has been approved at home.
• Source: Shutterstock

Patients and providers should not use COVID-19 tests from Cue Health because they may be inaccurate, the US Food and Drug Administration warned on 13 May.

The agency’s alert says that recent changes to Cue’s manufacturing process, which the company failed to notify the FDA about, have decreased the reliability of the tests. Tests that have...

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