Cue Health Makes De Novo Submission to FDA for Full Clearance of Its Molecular COVID-19 Test
A prior submission to the FDA for Emergency Use Authorization of Cue's COVID-19 at-home, over-the-counter test showed 98.9% accuracy. An independent study by
"This FDA submission marks a major milestone for the company and begins to define a new space of molecular testing in the home and at the point-of-care. We hope this will be the first of many submissions for Cue's molecular testing as we look to address a range of diseases and conditions and make healthcare more responsive, convenient, and effective," said
With an installed base of nearly a quarter million Cue Readers to date, Cue's COVID-19 test has been used by millions of Americans. Cue is a COVID-19 testing solution in a number of the nation's leading healthcare institutions, including
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 the Form 10-K dated
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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