New educational resources will make it easier for people at high risk of progression to severe COVID-19 to protect their health through accessible and timely health information
Cue Health (“Cue”) (Nasdaq: HLTH), the healthcare technology leader in at-home and point-of-care diagnostic innovations, today announced a new collaboration with Pfizer Inc. in the U.S. to raise awareness among individuals with certain underlying conditions about the risks of progressing to severe COVID-19 and the importance of seeking treatment if they test positive. Through Cue Care, Cue’s same-day, at-home, test-to-treatment platform, individuals will be able to use the Cue Health App to access educational resources like those available on Pfizer’s www.knowplango.com website, including information on risk factors for progression to severe illness from COVID-19, including hospitalization or death.
“The recent guidance from the CDC underscores the continued importance of testing even when symptoms are mild, timely access to healthcare providers, and, where appropriate, treatment for those most vulnerable to the COVID-19 variants in circulation,” said David Tsay, MD, PhD, chief medical officer at Cue Health. “Cue’s platform offers people support for each of those critical needs and is now integrating educational resources into Cue Care as part of this collaboration with Pfizer. Together, this actionable health information will help individuals make more informed decisions that can lead to better health outcomes.”
This COVID-19 collaboration with Pfizer builds on recent initiatives launched by Cue to rapidly connect at-risk individuals with providers for care and, where appropriate, treatment.
“Connected health solutions like the Cue platform offer potential for faster and more convenient access to care. Our collaboration provides an opportunity to improve the test-to-treatment experience for patients and communities at high risk, which includes people 50 years of age and older,” said JoyL Silva, Global and U.S. Antiviral Franchise Lead, Pfizer.
While these educational resources are specific to COVID-19 today, the Cue platform is designed to support a wide range of diagnostic test-to-treatment areas, and the company plans to make educational resources about treatment and recovery available for other respiratory viruses and sexual health conditions in the future.
Last month, Cue announced a partnership with Scripps Research Translational Institute to launch ImmunoCARE, a remote trial utilizing Cue’s test-to-treatment platform, aimed at reducing hospitalizations and other severe outcomes in immunocompromised people infected with SARS-CoV-2, the virus that causes COVID-19. Further, in December, Cue announced it was selected by the Minnesota Department of Health (MDH) to provide a statewide COVID-19 telehealth to treatment program at no cost to Minnesota residents, powered by Cue Care.
Cue’s COVID-19 test was the first molecular diagnostic test available to consumers without a prescription and is the most accurate at-home COVID-19 test*, delivering results in 20 minutes to connected mobile devices. It detects all known COVID-19 variants of concern in people with or without symptoms. Cue is used in homes, in point-of-care settings, and by world-class organizations across the country, including Mayo Clinic, Johns Hopkins Medicine, Google, and the National Basketball Association, among many others.
An independent study by Mayo Clinic, released in 2021, found Cue's COVID-19 test showed 97.8% concordance with central lab PCR tests.
*Accuracy claim based on comparison of clinical study results submitted to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization for Cue and other molecular home tests.
About Cue Health
Cue Health (Nasdaq: HLTH) is a healthcare technology company that makes it easier 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 those related to the expected future diagnostic test menu and the factors discussed in the “Risk Factors” section of Cue’s Annual Report on Form 10-K for the year ended December 31, 2021 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 filed with the SEC on November 9, 2022. 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.
Cue’s COVID-19 tests have not been FDA cleared or approved; but have been authorized by FDA and 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.
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