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FDA Authorizes Cue Health’s COVID-19 Test for At-Home and Over The Counter Use

March 5, 2021

Cue is the First to Offer Molecular Diagnostic Testing to Consumers in the U.S. Without a Prescription

  • FDA grants Emergency Use Authorization for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use for symptomatic and asymptomatic individuals, ages 2 and older
  • Prospective studies comparing the Cue OTC Test to a highly sensitive FDA-EUA authorized PCR laboratory-based test found 97.4% agreement for positive cases and 99.1% agreement for negative cases
  • Cue provides a fast, automated process from sample collection to results in about 20 minutes using a lower nasal swab

San Diego, CA (March 5, 2021) - – Cue Health Inc. (Cue) announced the healthcare technology company has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over the counter 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 Over The Counter (OTC) Use (Cue OTC Test) 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. 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.

“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. It is a highly sensitive and specific nucleic acid amplification test (NAAT) that runs on the rechargeable Cue Cartridge Reader, a reusable device which fits in the palm of your hand. 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. Together, these components make up the Cue Health Monitoring System to offer clinical-grade performance at home or in a non-clinical setting. 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.

Founded in 2010, Cue has worked for the last decade to develop an integrated, universal testing model and platform that could meet the healthcare demands of a global population, addressing many diagnostic needs.

About the Cue Health Monitoring System

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.

About Cue Health

Cue Health Inc. (“Cue”) is an ISO 13485-certified healthcare technology company focused on developing and manufacturing professional and consumer medical diagnostic products that can be used in clinical or at-home settings. Cue’s mission is to create tools that empower healthcare providers and consumers by increasing their access to actionable health data. Cue’s first product, the Cue Health Monitoring System with the Cue COVID-19 Test Cartridge, is a platform that provides diagnostic information to clinicians and patients seeking to benefit from a connected healthcare delivery ecosystem.

This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA; this test has been authorized only for the detection of nucleic acid from SARS CoV-2, not for any other viruses or pathogens; and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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