Cue Health awarded $28m BARDA contract for multiplex test for Flu, RSV, and COVID-19

Healthcare technology company Cue Health (Nasdaq: HLTH) announced that it has been awarded a contract worth approximately $28 million by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS). The contract is aimed at developing a molecular multiplex test for Flu A/B, RSV, and COVID-19 for both over-the-counter (OTC) and point-of-care (POC) use. The test would simultaneously detect and differentiate these viruses, delivering results in around 25 minutes to connected devices.

Cue Health’s Partnership with BARDA to Develop Multiplex Test

The development of this multiplex test addresses a critical healthcare need, as influenza, RSV, and COVID-19 are responsible for hundreds of thousands of hospitalizations in the U.S. every year. Cue’s diagnostic platform would be instrumental in providing actionable information that could lead to better health outcomes.

Ayub Khattak, Chairman and CEO of Cue Health, emphasized the importance of the project, stating, “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.”

Cue’s Regulatory Efforts and Previous Collaborations with BARDA

In addition to this development, Cue Health has also applied for Emergency Use Authorization (EUA) for its Cue Flu + COVID-19 Molecular Test and requested De Novo classification for the Cue RSV Molecular Test. The company’s work with BARDA began in 2018 and has included contracts to accelerate the development of various tests, including the first molecular test to receive FDA Emergency Use Authorization for at-home use without a prescription.

Cue Health Monitoring System and Manufacturing Capability

Cue’s molecular tests are designed to run on the Cue Health Monitoring System (Reader), with over a quarter-million installed bases. Manufacturing occurs at Cue’s San Diego headquarters, with flexible production and assembly lines allowing for real-time pivoting between different diagnostic tests.