Cue Health’s First-of-its-Kind COVID-19 Home Test Gets FDA Authorization

Cue Health’s over-the-counter molecular nucleic acid amplification test (NAAT) for COVID-19 has been granted FDA de novo authorization, making it the first traditionally authorized at-home test for any respiratory illness.

Cue’s NAAT product, previously available through an emergency use authorization, delivers results in about 20 minutes through a connected mobile smart device. The test correctly identified 99 percent of negative and 93 percent of positive samples, the company said.

The FDA said this test is an example of the agency’s continued work with test developers that want to market their products beyond emergency use authorities and “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.”

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