Cue Health, a healthcare technology company, announced it is the first company to receive De Novo authorization from the U.S. Food and Drug Administration (FDA) 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.

According to the company, this achievement highlights Cue Health’s dedication to empowering individuals with accurate, accessible, and actionable diagnostic tools. The FDA’s De Novo authorization signifies that the Cue COVID-19 Molecular Test meets the agency’s stringent regulatory standards for safety and efficacy.

Related: Cue Health Unveils New Suite of At-Home Tests

Originally made available to consumers without a prescription through a 2021 FDA Emergency Use Authorization (EUA), Cue’s COVID-19 test delivers results in just 20 minutes to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 test-to-treatment service.

“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,” says Ayub Khattak, Chairman and CEO of Cue Health. “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.”

This project has been funded in whole or in part with federal funds awarded by the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, beginning in June 2018 under contract number HHSO100201800016C.

Featured image: Cue Reader (Photo: Business Wire)