FDA OKs another over-the-counter Covid-19 test

Cue Health received an emergency use authorization for its at-home Covid-19 test to be used over-the-counter. Photo credit: Cue Health

The Food and Drug Administration gave the green light for another over-the-counter Covid-19 testing option. The agency gave an emergency use authorization to San Diego-based startup Cue Health for its molecular Covid-19 test on Friday.

It’s one of a handful of tests that can be used by patients without symptoms, including an at-home antigen test developed by Ellume and an at-home collection kit developed by Everlywell.

“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a news release.

Cue’s test uses a nasal swab, as well as a test cartridge and an at-home cartridge reader that syncs with a mobile app. It takes about 20 minutes to get results. Users have to create an account to view their results, and in the future, should be able to report their results to public health authorities from the app.

According to data shared by the FDA, it identified 96% of positive samples in individuals with symptoms and 100% of positive samples in individuals without symptoms.

A separate study conducted by Mayo Clinic at a drive-thru testing site found that it correctly identified 92% of cases in 24 patients that tested positive for Covid-19, and 98% of 243 patients that tested negative.

In October, Cue won a $481 million contract from the Department of Health and Human Services and the Department of Defense to ramp up manufacturing of its tests. The company initially said it planned to produce 100,000 test kits per day by March; now it expects to reach that threshold by the summer.


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