Cue Health, BARDA partnering on development of real-time Omicron-Genotyping COVID-19 Test

While Cue Health already has a COVID-19 test on the market capable of detecting the widespread omicron variant, the organization announced that it will work with the Biomedical Advanced Research and Development Authority (BARDA) to create a point-of-care test specifically focused on rooting out omicron.

The Omicron-Genotyping COVID-19 Test is being positioned to complement the company’s existing molecular test, which was the first to be U.S. Food and Drug Administration approved for at-home and over-the-counter use without prescription back in March 2021. While the latter provides at-home results through mobile devices within 20 minutes for anyone at least 2 years old and older, with or without symptoms, the new test will provide more advanced information and still be compatible with Cue’s monitoring system and mobile application.

“An Omicron-specific test will assist clinicians in providing patients better treatment options and containment strategies at the time of a positive diagnosis,” Ayub Khattak, co-founder and CEO of Cue, said. “We are proud to partner with BARDA to develop this new test, which will help eliminate guesswork, provide more choices for patients, and strengthen public health outcomes for communities.”

As part of their partnership, BARDA will provide Cue with additional funding to accelerate the development, validation, and regulatory authorization of a single-plex test designed solely to detect omicron in nasal samples. The company has already received millions from BARDA for its monitoring system over the last few years, as well as to accelerate work on what would become its SARS-CoV-2 test.