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# Cue Health EUA for At-Home Molecular Covid Test
- URL: https://www.fdaweb.com/cue-health-eua-for-at-home-molecular-covid-test/
- Published: 2021-03-05T12:00:00.000Z
- Updated: 2026-09-14T16:49:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148819

FDA has issued Cue Health an emergency use authorization for its Cue Covid-19 Test for home and over the counter use. The molecular nucleic acid amplification test is the first molecular test authorized for at-home use without a prescription, an agency release (XXINSRT LINKXX) says. It is intended for use in adults (self-swabbing) or children two years of age or older (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect Covid-19\. 

The authorization was based on data showing that the test correctly identified 96% of positive samples from individuals known to have symptoms and correctly identified 100% of positive samples from individuals without symptoms, according to the release. Cue Health expects to produce more than 100,000 tests per day by summer.