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FDA Warns Against Use of Cue Health COVID-19 Tests

NEW YORK – The US Food and Drug Administration has issued a warning letter recommending against the use of Cue Health's COVID-19 tests for home, over-the-counter, and patient care use due to an increased risk of false results. 

According to the agency's warning letter, the San Diego-based company implemented multiple changes to its COVID-19 tests without authorization from the FDA, including changes in the formulation of the substrate used for the test's reaction that is responsible for generating a signal to detect the presence of the target. The firm also added and modified additional components of its tests, including reagent formulations and device design, which "may negatively impact the stability of the devices, resulting in failure earlier than the nine months claimed on the product labeling," the FDA wrote. 

The modifications "were implemented with the intent to affect overall device performance and in particular device stability," the agency added. 

Cue did not submit a request for the changes or obtain FDA authorization for the changes, and the agency determined the updates are "significant modifications." Cue is no longer permitted to distribute the modified tests until authorization is received. The FDA requested Cue stop the sale and distribution of the tests until FDA concurrence for the modifications has been received. 

The agency also noted in its letter that Cue did not "ensure that tests released for distribution have the analytical and clinical performance claimed in the authorized labeling." 

For home test users, the agency recommended disposing of any Cue Health COVID-19 tests, talking to a healthcare provider if concerned about results provided by the Cue test, and considering retesting using a different COVID-19 assay if symptoms are still present and the Cue test returned a negative result. 

The agency also recommended healthcare providers dispose of any Cue COVID-19 tests and consider retesting patients using a different test if an inaccurate result is suspected. 

On Monday, Cue Health said in a statement that it is currently evaluating the letter and determining its response.