Cue Health (Nasdaq:HLTH) announced that it received FDA de novo authorization for its Cue COVID-19 molecular test.
San Diego-based Cue Health designed the test for both home and point-of-care use. Its authorization marks the first such nod for a home-use COVID-19 test, the company said. It also represents the first de novo authorization for any home-use respiratory test, according to a news release.
Cue Health originally made its COVID-19 test available to consumers without a prescription in 2021. That availability came under the FDA’s emergency use authorization (EUA), a widely used pathway for COVID-19-related products.
The molecular test delivers results in just 20 minutes to connected mobile smart devices. It demonstrated overall accuracy of 98%, detecting all known COVID-19 variants of concern. The test also integrates into Cue Care, the company’s state-of-the-art 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,” said Ayub Khattak, Cue Health chair and CEO. “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.”
Cue Health also seeks an FDA nod for its RSV test, having submitted to the agency last month.