SAN DIEGO, March 8, 2021 /PRNewswire/ -- Cue Health Inc. (Cue), a leading healthcare technology company, today 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.
"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.
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.
The Fierce 15 celebrates the spirit of being "fierce" — championing innovation and creativity, even in the face of intense competition. This is Fierce Medtech's 9th annual Fierce 15 selection. This year's full list of winners can be viewed online at: https://www.fiercebiotech.com/special-report/fierce-medtech-s-2020-fierce-15.
"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.
An internationally recognized daily report reaching a network of over 90,000 med tech industry professionals, Fierce Medtech provides subscribers with an authoritative analysis of the day's top stories. Every year Fierce Medtech evaluates hundreds of private companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.
About Fierce Medtech
Fierce Medtech keeps biopharma executives, device developers, engineers, and researchers updated on the must-know news, trends and developments in medical technology. More than 90,000 top industry professionals rely on Fierce Medtech for an insider briefing on the day's top stories.
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 product has not been FDA cleared or approved; but has been authorized by FDA under an EUA. This product has been authorized only for the detection of nucleic acid from SARS- CoV-2, not for any other viruses or pathogens. The emergency use of this product 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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SOURCE Cue Health Inc.