Cue Health to Develop Omicron-Genotyping COVID-19 Test in Partnership with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA)
The additional funding from BARDA will be used to accelerate the development, validation, and regulatory authorization of a single-plex assay designed solely to detect the Omicron variant in nasal samples. The new test will be compatible with the Cue Health Monitoring System and the Cue Health Mobile Application.
"An Omicron-specific test will assist clinicians in providing patients better treatment options and containment strategies at the time of a positive diagnosis," said
Cue has worked with BARDA since 2018, when the Company received
During the early stages of the pandemic, Cue's team of scientists and bioinformatic experts implemented a surveillance program to monitor and analyze all relevant SARS-CoV-2 variant sequences globally. These sequences are routinely compared to the primers in Cue's COVID-19 test to determine if any mutations are present that could affect the sensitivity or specificity of Cue's test. Cue's tests work by targeting a region of the nucleocapsid gene (n gene) that is highly conserved, and Company scientists have found that the test's accuracy has remained unaffected by the mutations in the Omicron variant and other variants of concern to date.
Cue 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 and can be used on adults and children (2 years and over), with or without symptoms, wherever they are.
*Based on clinical study results submitted to FDA for other EUA molecular home tests.
This project has been funded in whole or in part with federal funds from the
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FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription and physician supervision. Outside
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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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