Cue Health Makes De Novo Submission to FDA for Full Clearance of its Cue® Flu Molecular Test
Clinical study results with the Cue Flu Molecular Test were favorable, demonstrating 99% accuracy1 compared to FDA cleared molecular (PCR) laboratory tests for influenza A&B. The Cue Flu Molecular Test cartridge uses a lower nasal swab and is compatible with the Cue Reader, which communicates test results digitally via Bluetooth to a mobile device in approximately 25 minutes.
"This FDA submission for our Cue Flu Molecular Test is another important milestone on Cue's path to pioneer a new approach to diagnostics in homes, enterprises, and healthcare settings," said
Cue's molecular COVID-19 test, which is authorized by the FDA for home and POC use under an Emergency Use Authorization (EUA), is also currently under de novo review with the FDA. With an installed base of over a quarter million Cue Readers shipped to date, Cue's COVID-19 test has been used by millions of Americans. Cue is used by some of the nation's leading healthcare institutions, including
This project has been funded in whole or in part with Federal funds awarded by the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, in June 2018 under Contract No. HHSO100201800016C.
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
Cue's COVID-19 tests have not been FDA cleared or approved; but have been authorized by FDA and 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.
1 With discordance analysis using a second FDA-cleared laboratory PCR test
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