Cue Health awarded $28M federal contract

Cue Health announced that it has been awarded a new approximately $28 million contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services (HHS), to develop a Flu A/B, RSV, and COVID-19 molecular multiplex test for both over-the-counter (OTC) and point-of-care (POC) use. Cue’s test would detect and differentiate between influenza A, influenza B, respiratory syncytial virus (RSV), and COVID-19 simultaneously, with results delivered in approximately 25 minutes to connected smart devices. The company has also applied with the U.S. FDA for Emergency Use Authorization (EUA) for its Cue Flu + COVID-19 Molecular Test for at-home and point-of-care (POC) use. Cue also requested De Novo classification from the FDA for the Cue RSV Molecular Test for at-home and point-of-care use. In March, the company received an EUA from the FDA for the Cue Mpox (Monkeypox) Molecular Test, which can be performed at the point-of-care at any CLIA-waived facility.