Cue Health Provides Enhanced Care & Protection for Immunocompromised Populations & Clinical Care Teams at Fresenius Kidney Care
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
"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
Fresenius Kidney Care operates more than 2,600 dialysis centers in the
"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
Fresenius Kidney Care is one of the growing number of healthcare-affiliated organizations and internationally-recognized hospital systems throughout the
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.
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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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