FDA Authorizes Cue Health's COVID-19 Test for At-Home, OTC Use

Cue Health has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over-the-counter (OTC) sale of its fast, accurate, COVID-19 test, making it the nation's first molecular diagnostic test available to consumers without a prescription. The Cue COVID-19 Test for Home and OTC Use uses a lower nasal swab and 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 with adult assistance.

"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. "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. Our guiding principle has been to revolutionize diagnostics to transform health outcomes and we are so proud to lead this transformative paradigm shift in the U.S. healthcare system."

The Cue Home and OTC Test detects the RNA of SARS-CoV-2, the virus that causes COVID-19, with the accuracy of a central lab test. Results are displayed directly onto the user's mobile smart device via the Cue Health App. Each Cue OTC Test Cartridge Pack includes the single-use, self-contained Cue Test Cartridge and the Cue Sample Wand, which is the swab for minimally invasive sample collection. In prospective studies to evaluate the use of the Cue OTC Test, the results were 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.

"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."

The Cue COVID-19 Test received 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 U.S. in K-12 schools, essential businesses, nursing homes and other congregate-care facilities, hospitals, physicians' offices, dental clinics, and more. The test is also being distributed via a program led by the U.S. Department of Defense (DOD) and the U.S. Department of Health and Human Services (HHS) across several U.S. states.

The Cue Health Monitoring System is a portable, compact, connected diagnostic platform that provides the power of lab-quality molecular testing at point-of-care, when and where it is needed the most. The Cue Health Monitoring system works with the Cue Test Cartridge, the Cue Sample Wand, and the Cue Health App to convert test samples into accurate digital results. The Cue COVID-19 Test Cartridge is a single-use, self-contained, high-sensitivity molecular assay. The Cue Sample Wand is a lower nasal swab supplied with the Cue Test Cartridge. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the Cue Health App in about 20 minutes via a mobile smart device. The Cue Health App on the user's mobile smart device (available for iOS and Android) is the interface for test information, instructions, and display of the test results.