FDA Authorizes First Molecular At-Home, OTC COVID-19 Test

Megan Brooks

March 08, 2021

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter Use (Cue OTC Test, Cue Health Inc).

The Cue OTC Test is the first molecular diagnostic test available to consumers without a prescription.

The Cue OTC Test correctly identified 96% of positive nasal swab samples from individuals known to have symptoms and correctly identified 100% of positive samples from individuals without symptoms.

The test detects genetic material from SARS-CoV-2 present in the nostrils and delivers results in about 20 minutes to the user's mobile smart device via the Cue Health app.

In testing, the Cue OTC Test correctly identified 96% of positive nasal swab samples from individuals known to have symptoms and correctly identified 100% of positive samples from individuals without symptoms.

The test is intended for use in people aged 2 years and older with and without symptoms.

"With this authorization, consumers can purchase and self-administer one of the easiest, fastest, and most accurate tests without a prescription," Clint Sever, co-founder and chief product officer of Cue Health, said in a news release.

"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," he said.

Cue Health expects to produce more than 100,000 single-use test kits per day by this summer. Dena Cook, the company's chief communications officer, told Medscape Medical News the company hasn't announced pricing information yet but the price will be "comparable" to other price points and other products on the market.  

"The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic," Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, said in a statement.

"Cue COVID-19 Test for Home and Over-the-Counter Use provides access to accurate and reliable testing at-home, without a prescription. The FDA will continue to work collaboratively with test developers to advance effective testing options for doctors, clinicians, and the public," he said.

In June, the FDA granted an EUA to Cue Health's COVID-19 test for use in clinical and point-of-care settings.

The test is currently being used in hospitals, physicians' offices, and dental clinics, as well as schools, essential businesses, nursing homes, and other congregate-care facilities.

The test is also being distributed through a program led by the US Department of Defense and the US Department of Health and Human Services across several states.

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