Cue Health Receives De Novo Authorization From FDA For COVID-19 Molecular Test

(RTTNews) - Cue Health (HLTH), has receive De Novo authorization from the U.S. Food and Drug Administration for its Cue COVID-19 Molecular Test, designed for both home and point-of-care use.

This is the first FDA De Novo authorization for a home use COVID-19 test and the first De Novo granted for any home use respiratory test.

Originally made available to consumers without a prescription through a 2021 FDA Emergency Use Authorization, Cue's COVID-19 test delivers results in just 20 minutes to connected mobile smart devices.

With a demonstrated overall accuracy of 98%, the test detects all known COVID-19 variants of concern and integrates into Cue Care, the company's state-of-the-art test-to-treatment service.

Ayub Khattak, Chairman and CEO of Cue Health, said, "We are honored to receive this landmark De Novo authorization from the FDA, which emphasizes the reliability and accuracy of our COVID-19 Molecular Test in home and point-of-care settings. Our integrated test-to-treatment platform, coupled with the recent authorization of our mpox test and several other molecular tests under FDA review or in clinical studies, helps enable faster and better-informed healthcare decisions while making care and treatment more convenient."