Cue Health Achieves A Groundbreaking Milestone: Fda Grants De Novo Authorization For Covid-19 Home Use Test
Cue Health, a healthcare technology company listed on Nasdaq under the ticker symbol HLTH, has achieved a significant milestone 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 groundbreaking authorization applies to both home and point-of-care use, setting a new standard as 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.
The Cue COVID-19 Molecular Test was initially made available to consumers without a prescription through the FDA Emergency Use Authorization (EUA) in 2021. The test provides results within 20 minutes and can be viewed on connected mobile smart devices. With an impressive overall accuracy of 98%, the test can detect all known COVID-19 variants of concern. It integrates seamlessly into Cue Care, which is the company's advanced test-to-treatment service.
Ayub Khattak, Chairman and CEO of Cue Health, expressed his gratitude and pride in receiving this landmark De Novo authorization from the FDA. He emphasized the reliability and accuracy of the Cue COVID-19 Molecular Test in home and point-of-care settings. Khattak also highlighted the company's integrated test-to-treatment platform, which, together with the recent authorization of their mpox test and other molecular tests under FDA review or in clinical studies, aims to facilitate faster and more informed healthcare decisions while prioritizing convenience for patients.