NEW YORK – The US Food and Drug Administration announced on Tuesday that Cue Health's at-home molecular test for COVID-19 has received de novo marketing authorization.
The Cue COVID-19 Molecular Test is the first at-home over-the-counter assay for COVID-19 to be granted marketing authorization using a traditional premarket review pathway and the first at-home test authorized using a traditional premarket review pathway for any respiratory illness, the FDA said in a statement. The test detects SARS-CoV-2 in nasal swabs from adults with signs and symptoms of upper respiratory infection using nucleic acid amplification technology. It received Emergency Use Authorization from the FDA in March 2021.
The approval is "part of the FDA’s broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing," Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
The test runs on the Cue Cartridge Reader and returns results in about 20 minutes. In a study reviewed by the agency, the test correctly identified nearly 99 percent of negative and nearly 93 percent of positive samples.
In a statement, Cue Chairman and CEO Ayub Khattak said, "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 San Diego-based firm submitted its test to the FDA for de novo authorization in May 2022.