Cue Health to Provide Highly-Accurate, Molecular COVID-19 Tests to Johns Hopkins Medicine
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.
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*Based on clinical study results submitted to FDA for other EUA molecular home tests.
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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
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.
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MEDIA INQUIRIES press@cuehealth.com