FDA Issues EUA for First OTC COVID-19 Test

Cue Health's test is over the counter (OTC) and can be utilized at home.

The Food and Drug Administration (FDA) announced it had granted an Emergency Use Authorization (EUA) for Cue Health's Home and OTC Test.

With this EUA, it becomes the first molecular diagnostic test available to consumers without a prescription in the United States.

“For the first time, consumers can access laboratory-grade testing at home," Co-Founder and CEO of Cue Ayub Khattak, said.

Test takers use a lower nasal swab and it delivers results in about 20 minutes to the user's mobile smart device. The Cue OTC Test is authorized for use by symptomatic and asymptomatic individuals, adults and children ages 2 and older. Results are displayed directly onto the user's mobile smart device via the Cue Health app.

It is a highly sensitive and specific nucleic acid amplification test that runs on the rechargeable Cue cartridge reader, a reusable device.

The Cue COVID-19 Test received an EUA from the FDA in June 2020 for use in the clinical and point-of-care settings. The tests are currently being used in the US in K-12 schools, essential businesses, nursing homes and other congregate-care facilities, hospitals, physicians' offices, dental clinics, and more.