FDA advises against using Cue Health COVID-19 tests, sends warning letter

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Dive Brief:

• The Food and Drug Administration said Monday not to use Cue Health’s COVID-19 tests because of an increased risk of false results.
• FDA inspectors found Cue made unauthorized changes to its COVID-19 kits that “reduced the reliability of the tests to detect SARS-CoV-2 virus.” The findings triggered a warning letter.  
• The FDA published the warning letter alongside a safety alert that advised home test users and healthcare providers to dispose of Cue cartridges and consider retesting with a different product.

Dive Insight:

Cue expanded quickly in the pandemic as it secured investment and government and private contracts. The plan was to establish a diagnostic platform and portfolio of cartridges for different diseases to move testing from central labs to the home or point of care. However, COVID-19 sales collapsed before Cue could step up other revenue drivers, leading to a series of layoffs. 

FDA inspectors visited a Cue facility in San Diego in October and November. During the assessment, the inspectors found Cue had made “several changes” to its tests without seeking FDA authorization. The changes affected Cue’s tests for use in the home and in patient care settings.

Cue changed the formulation of a substrate involved in detecting the target, the FDA said, and modified the device firmware. The FDA said Cue made some of the changes to affect device performance, notably stability. The terms of the emergency use authorizations issued by the FDA require Cue to ask the agency before making such changes. 

The FDA also said Cue failed to comply with requirement for lot release activities to ensure the clinical and analytical performance of its tests. Cue’s procedures allowed for the release of tests that failed to hit performance claims, the FDA said. The agency said Cue could release products with an increased risk of false positive results.

The FDA sent the warning letter Thursday. On Monday, the agency made the warning letter public. Cue said in a statement it is “currently evaluating the letter and determining its response, with more information to follow in the next few days.” The company was scheduled to release its first quarter results Monday.