The Food and Drug Administration issued a warning to consumers not to use Cue Health’s at-home Covid-19 tests after the company failed to comply with the conditions outlined in its emergency use authorizations. In a letter, the FDA expressed concerns that changes made by Cue to the electrochemical signals in its test device could compromise the stability of the tests and lead to inaccurate results.
This latest development comes amidst a rocky period for Cue Health, which went public in 2021 with a valuation of nearly $3 billion. Despite this, the company provided tests for the NBA’s 2020 “bubble” and even received endorsements from Trump administration officials, leading to a $481 million deal to make its tests more widely available. However, the FDA warnings now cast doubt on the reliability of Cue Health’s tests, raising concerns among consumers about their effectiveness in detecting Covid-19.
The FDA has been keeping a close eye on at-home Covid-19 testing due to concerns over false negatives and positives. To address these issues, the agency has issued several guidance documents and emergency use authorizations for various at-home test providers. However, some companies have made unauthorized changes to their testing procedures without proper oversight or validation from regulatory authorities.
Cue Health is just one example of such companies that have faced scrutiny from regulators for making unauthorized changes to their testing procedures. In addition to violating emergency use authorization conditions, Cue was also found guilty of selling its products directly to consumers without proper labeling or instructions. These actions put consumers at risk of receiving incorrect results or interpreting them incorrectly.
As a result of these violations, Cue has been forced by regulators to halt sales of its at-home Covid-19 tests until they can comply with federal regulations once again. This is just one example of how regulatory oversight can help ensure that consumer products are safe and effective in detecting diseases like Covid-19.
