FDA issues EUA for first molecular non-prescription, at-home test

March 8, 2021

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Cue COVID-19 test for use at home and over the counter (OTC), according to a news release from the agency.

The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription.

The FDA had previously granted an EUA for the test to be used at the point-of-care.

With the new EUA, the test now is authorized for non-prescription home use for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal (nasal) swab specimens collected with the Cue Sample Wand. This test 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 authorized test includes: the single-use Cue COVID-19 Test Cartridge, the single-use Cue Sample Wand nasal swab, the Cue Cartridge Reader (used by the Cue Health Monitoring System, provided separately), and the Cue Health Mobile Application (App) that is downloaded onto compatible mobile smart devices, like a smart cell phone.

The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the Cue Health App in about 20 minutes. The mobile application requires individuals to create an account, and in the future will be updated to include capability to report test results as appropriate to public health authorities to monitor disease prevalence.

When used correctly, the Cue COVID-19 identified 96% of positive samples from individuals known to have symptoms and correctly identified 100% of positive samples from individuals without symptoms. Cue Health expects to produce more than 100,000 tests per day by summer 2021.

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