Cue Health, a healthcare technology company, has been awarded a contract worth around $28 million by the Biomedical Advanced Research and Development Authority (BARDA).
The contract is to develop a multiplex test for the detection and differentiation of influenza A, influenza B, respiratory syncytial virus (RSV), and COVID-19. The test will be available for both over-the-counter and point-of-care use, and will deliver results in approximately 25 minutes to connected smart devices.
The company has also applied for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Cue Flu + COVID-19 Molecular Test for at-home and point-of-care use, as well as 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.
Influenza, RSV, and COVID-19 are all serious respiratory viruses, particularly for those with weakened immune systems, older adults, and infants. According to the Centers for Disease Control and Prevention (CDC), these viruses are responsible for hundreds of thousands of hospitalizations each year. The flu alone caused between 27 million and 54 million illnesses during the 2022-2023 respiratory season, while approximately 7,000 people are still admitted to the hospital per week due to COVID-19 in the U.S.
“We’re proud to be able to expand our partnership with BARDA and provide a diagnostic platform to detect and differentiate between influenza A, influenza B, RSV, and COVID-19,” said Ayub Khattak, CEO of Cue Health.