Cue Health Inc. (Cue), a leading healthcare technology company, announced that it has been named by Fierce Medtech as one of 2020’s Fierce 15, designating it as one of the most promising private companies in the industry. Cue’s mission is to make molecular diagnostic testing available to anyone, anywhere, at any time through a connected healthcare delivery ecosystem.
On March 5, 2021, Cue received EUA from the 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.
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“We are honored to be recognized as one of the ‘Fierce 15’ for our work,” said Clint Sever, Co-Founder and Chief Product Officer of Cue. “Cue’s mission is to make molecular diagnostic testing available to anyone, anywhere, at any time through a connected healthcare delivery ecosystem. The FDA’s EUA for home and OTC use is an important step towards realizing this vision.”
Cue’s COVID-19 test is a highly sensitive and specific nucleic acid amplification test (NAAT) that detects the RNA of SARS-CoV-2, the virus that causes COVID-19. The test runs on the Cue Health Monitoring System, a portable, easy-to-use, connected diagnostic platform that provides the power of fast and accurate lab-quality molecular testing at point-of-care.
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The Cue COVID-19 Test is currently being used in the U.S. in point-of-care settings, such as K-12 schools, essential businesses, nursing homes and other congregate-care facilities, hospitals, physicians’ offices, dental clinics, and more. The test is also being utilized 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.
“Each member of this year’s class of Fierce 15 stands out in a different way, but they all overcame a year of unforgettable obstacles, making each of their successes that much more significant — and all have the potential to deliver changes in healthcare that promise to outlast this pandemic,” said Conor Hale, associate editor of Fierce Medtech.
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