Cue Health, a healthcare technology company, has achieved a significant breakthrough by becoming the first company to receive De Novo authorization from the U.S. Food and Drug Administration (FDA) for its Cue COVID-19 Molecular Test. This authorization is notable as it marks the first FDA De Novo authorization for a home use COVID-19 test and the first for any home use respiratory test.
The Cue COVID-19 Molecular Test, which was initially available to consumers without a prescription through a 2021 FDA Emergency Use Authorization (EUA), provides results in just 20 minutes and can be connected to mobile smart devices. The test has demonstrated an overall accuracy of 98% and is capable of detecting all known variants of concern related to COVID-19.
Cue Health's test seamlessly integrates with their Cue Care platform, a state-of-the-art test-to-treatment service. This integration enables faster and more informed healthcare decisions, making care and treatment more convenient for individuals.
It is worth noting that the project leading to the development of the Cue COVID-19 Molecular Test received federal funding from the Department of Health and Human Services, specifically from the
Administration for Strategic Preparedness and Response and the Biomedical Advanced Research and Development Authority.
The FDA's De Novo authorization highlights the reliability, accuracy, and safety of the Cue COVID-19 Molecular Test in both home and point-of-care settings. This authorization sets a new standard for accessible and actionable diagnostic tools for COVID-19 testing.