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Cue Health Lays off 94 People as FDA Declines to Grant COVID/Flu Test EUA

NEW YORK – Cue Health this week implemented a new cost-reduction plan, laying off 94 people, or approximately 13 percent of its workforce, according to a document filed with the US Securities and Exchange Commission on Friday.

The plan is intended to reduce the company's cost structure and improve its operational efficiency, and employee termination dates are expected to occur in early March, the company said in its filing. Cue will record an aggregate restructuring charge between $2.1 million and $2.8 million related to one-time termination benefits. 

Cue previously implemented cost-reduction plans in January and April 2023 that included layoffs of 388 and 326 employees, respectively.

The firm also announced in its form 8-K that the US Food and Drug Administration declined to issue Emergency Use Authorization for the company's combination influenza A/B and COVID-19 molecular test for over-the-counter and point-of-care use. 

A letter from the FDA said that further review of Cue's EUA request is not a priority, and that the decision to decline the EUA request is based on "review of the submission thus far, including significant issues identified, FDA priorities relating to the COVID-19 testing landscape, and the anticipated FDA resources needed to continue review of the EUA request," Cue said in its SEC filing.