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Cue Receives CE Mark for Its Molecular Point-of-Care COVID-19 Test

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SAN DIEGO, Feb. 23, 2021 /PRNewswire/ Cue Health Inc. (Cue), a healthcare technology company, today announced its molecular point-of-care COVID-19 Test has received the CE mark, clearing it for sale and distribution in the European Union (EU).
The Cue COVID-19 Test is a highly sensitive and specific nucleic acid amplification test (NAAT) that runs on the Cue Health Monitoring System, displaying test results directly on a connected mobile smart device in about 20 minutes via the Cue Health App. The Cue COVID-19 Test consists of the Cue Test Cartridge, which is a single-use, self-contained, high-sensitivity molecular assay, and the Cue Sample Wand, a lower nasal swab for minimally invasive sample collection. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the Cue Health App. Altogether, the Cue COVID-19 Test and the Cue Health Monitoring System is a portable and ....

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Cue Health's Connected Point-of-Care COVID-19 Test Demonstrates 97.8% Agreement When Compared to Central Lab PCR Testing in an Independent Clinical Validation Study

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SAN DIEGO, Feb. 11, 2021 /PRNewswire/ Cue Health Inc. (Cue) announced today the results of an independent clinical validation study conducted by Mayo Clinic Laboratories evaluating the accuracy of Cue s COVID-19 Test in the point-of-care setting against the centralized lab PCR testing model. The study, which was published in
Diagnostic Microbiology and Infectious Diseases, included samples from 292 patients at a collection site operated by the Mayo Clinic Health System. The study found that the overall concordance between the Cue point-of-care test and the reference laboratory tests was 97.8%. This is one of the only real-world clinical evaluations to date to compare the accuracy of molecular point-of-care and gold-standard central laboratory tests using samples obtained prospectively from patients, and not using archived or previously tested specimens. ....

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Cue's Molecular, Point-of-Care COVID-19 Tests Now Available in 10 States Under Health and Human Services and Department of Defense Pilot Program

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SAN DIEGO, Jan. 19, 2021 /PRNewswire/ Cue Health Inc. (Cue) announced today that its molecular, point-of-care COVID-19 Tests are being distributed to five additional states, including Colorado, Minnesota, Pennsylvania, Rhode Island and Utah, as part of the joint $481 million program with the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD). This expansion doubles the number of states participating in the program. Cue expects to deliver six million tests by the spring. Cue s COVID-19 Tests are being used in point-of-care settings to provide molecular confirmation to antigen tests that yield positive and suspicious negative results, eliminating the need to send results to a central lab and thereby enabling healthcare providers to respond immediately. ....

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