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Cue Health Over-the-Counter COVID-19 Test Gets FDA Emergency Use Authorization

NEW YORK – The US Food and Drug Administration late on Friday said that it has granted Emergency Use Authorization to the Cue COVID-19 Test for home and over-the-counter use.

Cue's test is a nucleic acid amplification assay intended to detect genetic material from SARS-CoV-2 virus present in the nostrils, and is the first molecular test authorized by the agency for at-home use without a prescription.

"The authorization of this new diagnostic test underscores FDA's goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans," Acting FDA Commissioner Janet Woodcock said in a statement.

The test from San Diego-based Cue Health qualitatively detects SARS-CoV-2 nucleic acid in anterior nasal swab specimens collected with the Cue Sample Wand. The test is intended for use in adults (self-swabbing) or children two years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19.

The test kit runs on the Cue Cartridge Reader, which is provided separately. The reusable, battery-operated cartridge reader runs the test cartridge and communicates results directly to a downloadable mobile app in about 20 minutes.

FDA said that the test correctly identified 96 percent of positive samples from individuals known to have symptoms and correctly identified 100 percent of positive samples from those without symptoms. Cue expects to produce more than 100,000 tests per day by summer 2021.

The company previously won FDA EUA for a similar test based on isothermal amplification for use in CLIA-certified labs or at the point of care. The firm has been quickly ramping up production of that assay with the help of multiple government awards.