Cue Health announced Friday it has received Emergency Use Authorization from the U.S. Food and Drug Administration for over-the-counter sales of a COVID-19 test that the San Diego biotech company says can deliver results in about 20 minutes.
Cue Health's lower nasal swab test provides results to a user's mobile smart device. It is authorized for use by symptomatic and asymptomatic individuals, adults and children ages 2 and older with adult assistance, according to the company.
Cue Health co-founder and CEO Ayub Khattak called it "the first molecular diagnostic test available without a prescription. For the first time, consumers can access laboratory-grade testing at home."
According to the company, the test detects the RNA of SARS-CoV-2, the virus that cause COVID-19, then displays results on a user's device via Cue Health's app.
The company says prospective studies evaluating its use were 97.4% in agreement for positive cases and 99.1% in agreement for negative cases when compared to the results of a PCR laboratory-based test.
Clint Sever, Cue's co-founder and chief product officer said, "This FDA authorization will help us improve patient outcomes with a solution that provides the accuracy of central lab tests, with the speed and accessibility required to address emergent global health issues."
The company previously received Emergency Use Authorization in June to have the test administered under the supervision of qualified medical personnel, and Cue Health says the tests are currently being used in settings such as K-12 schools, essential businesses, and hospitals.
Last fall, the company received a $481 million award from the Department of Defense to expand production and distribution of the tests, which are manufactured at the company's San Diego facilities.
