SAN DIEGO, Aug. 24, 2022 /PRNewswire/ -- Cue Health Inc. ("Cue") (Nasdaq: HLTH), a healthcare technology company, today announced a new collaboration with Fresenius Kidney Care to provide the most accurate* COVID-19 self-test to certain patients and clinical care teams.
People who are immunocompromised have been disproportionately affected by COVID-19 throughout the pandemic and remain highly dependent on measures that reduce the likelihood of infections, including vaccination. Cue can be used by vulnerable patient populations and their care partners to detect and treat COVID-19 early, often before complications arise and hospitalization is required. This is especially important in remote locations where timely and accurate results are critical for making clinical treatment decisions. Fresenius Kidney Care in Hawaii, Alaska, Puerto Rico, Guam, and Saipan will use the Cue Health Monitoring System and Cue COVID-19 Test to screen employees and test symptomatic immunocompromised patients in-center and at-home.
"This is a great example of how Fresenius Kidney Care is seeking out the best technologies to ensure we do everything we can to protect our vulnerable patient population from COVID-19," said Ines Dahne-Steuber, President of Spectra Laboratories, a Fresenius Medical Care company providing laboratory diagnostics to dialysis centers across the country. "This collaboration with Cue will help us provide patients with greater access to high-quality timely diagnosis and care in our effort to improve health outcomes while lowering costs."
Fresenius Kidney Care operates more than 2,600 dialysis centers in the U.S., providing more than 200,000 patients annually with services that include at-home peritoneal dialysis, at-home hemodialysis, in-center hemodialysis, and additional clinical care resources.
"By utilizing Cue's platform, Fresenius Kidney Care can continue to provide its life-saving services to immunocompromised patients with confidence they are using the most accurate COVID-19 self-test," said Ayub Khattak, Chairman and CEO of Cue Health. "We treat accuracy as non-negotiable so healthcare-affiliated organizations across the country can continue to trust Cue for their testing needs in high-stakes environments."
Fresenius Kidney Care is one of the growing number of healthcare-affiliated organizations and internationally-recognized hospital systems throughout the U.S working with Cue to transform how diagnostic healthcare is delivered to close gaps in the patient journey and drive improved health outcomes. Cue is used in many other point-of-care settings such as Johns Hopkins Medicine and Mayo Clinic, by world-class organizations across the country, including Google, the National Basketball Association, and Major League Baseball, and in homes.
Cue's test uses molecular nucleic acid amplification technology (NAAT) providing lab-quality results directly to connected mobile devices in 20 minutes. The test can detect all known COVID-19 variants and subvariants of concern - including Omicron, BA.4, and BA.5 - and can be used on adults and children (age 2 years and over for over-the-counter (OTC) / home use and under 2 for professional use), with or without symptoms.
*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 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 June 30, 2022 filed with the SEC on August 10, 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.
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.
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