Cue Health to Provide Highly-Accurate, Molecular COVID-19 Tests to Johns Hopkins Medicine
Cue’s molecular test is the most accurate COVID-19 self-test, providing lab-quality results in 20 minutes
San Diego, CA, February 7, 2022 — Cue Health (“Cue”) (Nasdaq: HLTH), a healthcare technology company, today announced it will provide Cue Health Monitoring Systems and Cue COVID-19 tests to Johns Hopkins Medicine (JHM), which includes Johns Hopkins University School of Medicine and The Johns Hopkins Hospital and Health System.
The portable monitoring system and tests will be utilized by physicians, scientists, health professionals, faculty and staff as part of JHM’s commitment to health and well-being among its entire employee population. In addition, JHM will have access to a Cue Health Enterprise Dashboard, which allows for test results to be shared through a secure, web-based internal application. This helps organizations manage population health and access timely data and analytics to enable administrators to swiftly identify trends and make informed decisions.
Cue’s test uses molecular nucleic acid amplification technology (NAAT) and is the most accurate* self-test for COVID-19, providing lab-quality results directly to connected mobile devices in 20 minutes. The test is able to detect all known COVID-19 variants, including Omicron, and can be used on adults and children (age 2 years and over for OTC/home use and under 2 for professional use), with or without symptoms.
“Johns Hopkins Medicine is playing a leading and critical role in the fight against COVID-19, and we are honored to help support their team’s health and well-being,” said Ayub Khattak, Co-Founder and CEO of Cue. “In settings like hospitals and medical research facilities, accuracy cannot be compromised and precision is paramount. That’s why world-class healthcare organizations like Johns Hopkins Medicine turn to Cue. We provide the confidence in self-testing and access to real-time health information that’s highly valued for those on the frontlines of this pandemic.”
Johns Hopkins Medicine is one of several healthcare-affiliated organizations to which Cue provides its tests, including internationally-recognized hospital systems throughout the U.S.. Cue also provides tests to Google, the National Basketball Association, and Major League Baseball, among other organizations.
*Based on clinical study results submitted to FDA for other EUA molecular home tests.
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.
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 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.
The Cue COVID-19 Test for Home and Over The Counter (OTC) Use and the Cue COVID-19 Test (for professional use) 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.
February 7, 2022
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