POC Molecular Multiplex Test to Detect and Differentiate Between Common Respiratory Viruses in 25 Minutes

Influenza, RSV, and COVID-19 are prevalent respiratory viruses that can have serious consequences, particularly for older adults, immunocompromised individuals, and infants. Together, these viruses cause a substantial number of hospitalizations every year. Now, a new test is being developed to detect and differentiate between influenza A, influenza B, respiratory syncytial virus (RSV), and COVID-19 simultaneously. This test will provide results in just about 25 minutes and deliver them to connected smart devices.

Cue Health Inc. (San Diego, CA, USA) has secured a BARDA contract of approximately USD 28 million to develop a molecular multiplex test for Flu A/B, RSV, and COVID-19. The test will be designed for both over-the-counter (OTC) and point-of-care (POC) usage. Cue Health's collaboration with BARDA dates back to 2018, when the company received initial funding to expedite the development and regulatory validation of OTC and professional use flu test cartridges, along with the Cue Health Monitoring System and cartridge manufacturing technology. In 2020, Cue Health was awarded another BARDA contract to accelerate the development, validation, and FDA clearance of its COVID-19 test, which became the first molecular test to receive FDA Emergency Use Authorization for at-home and over-the-counter use without a prescription.

Furthermore, Cue Health has applied to the FDA for Emergency Use Authorization (EUA) for its Cue Flu + COVID-19 Molecular Test, intended for at-home and POC usage. The company has also sought De Novo classification from the FDA for the Cue RSV Molecular Test, designed for at-home and POC use. Additionally, Cue Health obtained an EUA from the FDA for its Cue Mpox (Monkeypox) Molecular Test in March. This particular test can be used at the POC in any CLIA-waived facility. All of Cue Health's molecular tests run on the Cue Health Monitoring System (Reader), which boasts an installed base of over a quarter million units.

“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,” said 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.”

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