SAN DIEGO and DUBLIN, Ohio, Feb. 17, 2022 /PRNewswire/ -- Today Cue Health Inc. (Nasdaq: HLTH), a healthcare technology company, and Cardinal Health (NYSE: CAH) announced expanded distribution of Cue's professional use and over-the-counter COVID-19 tests.
Cue selected Cardinal Health, which serves nearly 90% of US hospitals and over 60,000 pharmacies, as one of its primary distributors due to a demonstrated expertise in helping commercialize diagnostic technologies. This relationship will help accelerate the reach of Cue's innovative nucleic acid amplification test (NAAT) into both traditional and non-traditional healthcare settings.
"Customers across the country trust Cardinal Health to deliver high-quality laboratory products, and Cue shares a goal with them of placing diagnostic information at the center of care," said Ayub Khattak, Co-Founder and CEO of Cue. "We look forward to making Cue's highly accurate, fast, and easy-to-use testing and access to real-time health information more widely available through our collaboration with Cardinal Health."
Health professionals and other qualified point-of-care test users can now purchase the Cue Health Monitoring System, the Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories (Professional), and Cue COVID-19 Test Positive Control Swabs and Test Negative Control Swabs through the vast Cardinal Health laboratory distribution network. An independent study by Mayo Clinic showed Cue's COVID-19 test to be in 97.8% overall concordance with central lab PCR testing.
Additionally, the Cue COVID-19 Test for Home and Over The Counter (OTC) Use (OTC/Home) – the first molecular diagnostic test of any kind available for use at home or in other non-clinical settings without a prescription to receive Emergency Use Authorization (EUA) from the FDA – is also available through Cardinal Health. Cue's molecular OTC/home test is the most accurate COVID-19 self-test*, can be used on adults and children (2 years and over) with or without symptoms, and is available for use at home or in other non-clinical settings without a prescription.
"Cue adds an important dimension to our suite of COVID-19 diagnostic solutions, further enhancing Cardinal Health's comprehensive offering to meet our customers' evolving testing needs," said Chris Kerski, Senior Vice President and General Manager, Cardinal Health Laboratory Products. "Cue's unique technology and platform combines molecular testing with speed and convenience, meeting the demands of health providers, employers, travelers, and others."
Both the professional and the OTC/home products will be available in packs of 10 tests. The durable, rechargeable Cue Health Monitoring System (Reader) communicates test results to the user's connected mobile smart device in 20 minutes through the Cue Health App, securely and conveniently.
In addition to highly accurate COVID-19 testing products, Cue offers 24/7 on-demand virtual care from board-certified physicians and in-app supervised testing through its Cue+™ membership program. The proctored service provides certified results to help users meet COVID-19 requirements for international air travel into the United States, Canada, and many other countries.
About Cue Health
Cue Health (Nasdaq: HLTH) is a healthcare technology company that makes it easy for individuals to access health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health's first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription and physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, regulatory approval from India's Central Drugs Standard Control Organization, and PSAR authorization from Singapore's Health Sciences Authority. Cue was founded in 2010 and is headquartered in San Diego. For more information, please visit www.cuehealth.com.
About Cardinal Health
Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities. With 50 years in business, operations in more than 30 countries and approximately 44,000 employees globally, Cardinal Health is essential to care. Information about Cardinal Health is available at cardinalhealth.com.
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements". The words, without limitation, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including those related to the expected future diagnostic test menu and the factors discussed in the "Risk Factors" section of the Form 10-Q dated November 10, 2021 filed by Cue with the SEC. Any forward-looking statements contained in this press release are based on the current expectations of Cue's management team and speak only as of the date hereof, and Cue specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
These products have not been FDA cleared or approved; but have been authorized by FDA under an Emergency Use Authorization (EUA). These products have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of these products 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.
*Based on clinical study results submitted to FDA for other EUA molecular home tests.
SOURCE Cue Health Inc.