The FDA’s marketing authorization for Cue’s COVID-19 molecular test could boost consumer access, but the company faces strong competition from more established diagnostic firms.

Cue Health's first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription and physician supervision.

became the first company to receive De Novo authorization from the FDA for its Cue COVID-19 Molecular Test, designed for both home and point-of-care use. The de novo is a device classification ...

Cue’s COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription.

Cue Health received Emergency Use Authorizations (EUAs) from the FDA in 2020 and 2021 to sell two COVID-19 tests, one for home use and one for clinical use, the agency said in a release.

Originally made available to consumers without a prescription through a 2021 FDA Emergency Use Authorization, Cue's COVID-19 test delivers results in just 20 minutes to connected mobile smart devices.

Cue’s accurate, fast, and reliable results make the easy-to-use test a convenient, cost-effective option for diagnosing patients at the office.

The nucleic acid amplification test is run on a Cue Reader, and delivers results in 25 minutes. Cue Health noted that it is the company's first non-COVID test to receive FDA authorization.

(RTTNews) - Cue Health (HLTH), has receive De Novo authorization from the U.S. Food and Drug Administration for its Cue COVID-19 Molecular Test, designed for both home and point-of-care use.