FDA authorizes Cue COVID-19 test as first molecular non-prescription, at-home diagnostic

A molecular test for COVID-19 can now be used at home without a prescription, following the U.S. Food and Drug Administration’s (FDA) granting of emergency use authorization (EUA) to the Cue COVID-19 Test for Home and Over the Counter (OTC) Use.

A molecular nucleic acid amplification test (NAAT), the Cue test works by detecting genetic material from SARS-CoV-2 — the virus that causes COVID-19 — in the nostrils. This can be done with a simple swab, known as the Cue Sample Wand. Adults may use the test themselves or use it on children at least two years old, with or without symptoms of COVID-19.

“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. “The FDA will continue to expand Americans’ access to testing to help us in the fight against this pandemic, which has claimed over half a million lives in the United States.”

In tests, the Cue test — produced by Cue Health — correctly identified 96 percent of positive samples from patients known to have symptoms of COVID-19. It also correctly identified 100 percent of positive samples from those without symptoms.

As authorized, the test comes in a package including a single-use test cartridge and nasal swab, the Cue Cartridge Reader, and the Cue Health Mobile Application, which can be downloaded onto compatible mobile smart devices. The test cartridge is run through the reusable, battery-operated cartridge reader, which then runs the results to the Cue Health App within approximately 20 minutes.

Cue Health said it anticipated the production of more than 100,000 tests per day by the summer.