Sam Brusco, Associate Editor06.07.23
Cue Health has become the first company to achieve de novo authorization from the U.S. Food and Drug Administration (FDA) for its Cue COVID-19 molecular test for both home and point-of-care use. It’s the first home COVID-19 test granted the de novo authorization and the first de novo granted for any home respiratory test.
The test was originally available to consumers without prescription in the 2021 FDA emergency use authorization (EUA). The test generates results in 20 minutes to connected smart mobile devices. It has a demonstrated overall accuracy of 98% and spots all known COVID-19 variants of concern.
Ayub Khattak, Chairman and CEO of Cue Health, told the press, "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."
The project was funded with federal funds awarded by the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority.
The test was originally available to consumers without prescription in the 2021 FDA emergency use authorization (EUA). The test generates results in 20 minutes to connected smart mobile devices. It has a demonstrated overall accuracy of 98% and spots all known COVID-19 variants of concern.
Ayub Khattak, Chairman and CEO of Cue Health, told the press, "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."
The project was funded with federal funds awarded by the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority.