Cue Health, a healthcare technology company, 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. 

Addressing Significant Respiratory Diseases

Influenza, RSV, and COVID-19 are common respiratory viruses that can be serious, especially for older adults, those with weakened immune systems, and infants. Combined, these viruses are responsible for hundreds of thousands of hospitalizations each year. RSV is the leading cause of hospitalization among children less than one year of age in the U.S. The flu alone caused between 27 million and 54 million illnesses last respiratory season (2022-2023), according to the Centers for Disease Control and Prevention (CDC). And approximately 7,000 people are still admitted to the hospital per week due to COVID-19 in the U.S, per CDC data as of July 15, 2023. 

“By expanding our successful partnership with BARDA, we’re able to meet a critical health need by utilizing Cue’s diagnostic platform to detect and differentiate between some of the most common respiratory viruses that have similar symptoms but distinct treatment options,” says Ayub Khattak, Chairman and CEO of Cue Health. “We expect this test will arm individuals and their providers with actionable information that can reduce community spread, increase the efficacy of treatment, and help lead to better health outcomes. We’re honored to be called upon once again to partner with BARDA to strengthen the nation’s emergency preparedness, and in doing so, empower more people to live their healthiest lives.” 

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.