On Friday, the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) of an over-the-counter COVID-19 test from Cue Health, the first COVID-19 molecular diagnostic approved by the FDA for use without a doctor’s prescription.
“This is the first molecular diagnostic test available without a prescription. For the first time, consumers can access laboratory-grade testing at home. This is an important milestone in the advancement of COVID-19 testing,” said Ayub Khattak, co-founder and CEO of Cue in a press release. “With this FDA authorization, we are one step closer to achieving our mission of making molecular diagnostic testing available to anyone, anywhere, at any time through a connected healthcare delivery ecosystem.”
Cue’s COVID-19 test—called the Cue OTC Test—is authorized for use by asymptomatic and symptomatic individuals, adults and children 2 years and older with adult assistance. The test uses a lower nasal swab and delivers results in about 20 minutes to a user’s mobile device. The test will offer users the convenience of an OTC product and the ability to test frequently.
With an easy-to-use, fully guided experience, the Cue OTC Test offers convenience, privacy, safety, and the ability to test frequently, with the accuracy of a centralized lab test. According to Cue, its test has shown accuracy that rivals the results from a centralized lab, touting 97.4% agreement for positive cases and 99.1% agreement for negative cases compared to the results from a highly sensitive EUA PCR laboratory-based test.
The test detects the RNA of the SARS-CoV-2 virus. The nucleic acid amplification test (NAAT) runs on the rechargeable Cue Cartridge reader, a small reusable device that connects to a person’s smartphone or other smart technology platform and delivers the results via the Cue Health app. The consumable portion of the test includes a single-use test cartridge and a sample wand designed for minimally invasive sample collection.
“With this authorization, consumers can purchase and self-administer one of the easiest, fastest and most accurate tests without a prescription,” said Clint Sever, co-founder and chief product officer of Cue. “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.”
Cue originally received emergency use approval for its COVID-19 test last June for use in clinical and point-of-care settings. The test is built on the company’s Cue Health Monitoring System that company has been developing for a broad array of diagnostic applications, leveraging mobile devices to deliver results and information on their use. The company, founded in 2011, state that it is “transforming how we detect disease and protect our health by making diagnostic testing available to anyone, anywhere, anytime.”
