Cue Health Inc. 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. Cue was awarded a contract by BARDA in 2020 to accelerate the development, validation, and FDA clearance of its COVID-19 test, which was the first molecular test to receive FDA Emergency Use Authorization for at-home and over-the-counter use without a prescription.

Cue also recently received De Novo authorization from the FDA for the same COVID-19 test (Cue COVID-19 Molecular Test), which was the first De Novo granted for any home use respiratory test available without a prescription. Cue?s work with BARDA began in 2018 when the company received base funding to accelerate the development and regulatory validation of over-the-counter and professional use flu test cartridges, the Cue Health Monitoring System, and cartridge manufacturing technology. The Cue molecular tests all run on the Cue Health Monitoring System (Reader), which has an installed base of more than a quarter million.

Cue?s molecular tests are manufactured at its San Diego headquarters, where production and assembly lines have the built-in capability to pivot between manufacturing different Cue diagnostic tests in near real-time. This project is being funded in whole or in part with federal funds from the Department of Health and Human Services; Administration of Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50123C00036.