Meridian Bioscience Corrects Prior Update Regarding Revogene® SARS-CoV-2 EUA Withdrawal

By Globe Newswire2 days ago

CINCINNATI, Feb. 23, 2021 (GLOBE NEWSWIRE) -- Meridian Bioscience, Inc. (NASDAQ:VIVO), a provider of diagnostic testing solutions and life science raw materials, updated its communication regarding the withdrawal of its application for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) for the SARS-CoV-2 molecular diagnostic test on its Revogene® platform.

In subsequent communication with the FDA mid-morning on February 23, 2021, the FDA clarified that Meridian will not be able to distribute its SARS-CoV-2 molecular diagnostic test on its Revogene® platform until the test receives EUA approval from the FDA. This corrects the Company's prior statement that the Company would resume shipping the Revogene® SARS-CoV-2 test to customers upon notification of its intent to re-submit an EUA application.

FORWARD-LOOKING STATEMENTS

The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, which may be identified by words such as “continues“, “estimates“, “anticipates“, “projects“, “plans“, “seeks“, “may“, “will“, “expects“, “intends“, “believes“, “signals“, “should“, “can“, “guidance“ and similar expressions or the negative versions thereof and which also may be identified by their context. All statements that address operating performance or events or developments that Meridian expects or anticipates will occur in the future, including, but not limited to, statements relating to per share diluted net earnings, sales, product demand, revenue, operating margin, other guidance and the impact of COVID-19 on its business and prospects, are forward-looking statements. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. Specifically, Meridian's forward-looking statements are, and will be, based on management's then-current views and assumptions regarding future events and operating performance. Meridian assumes no obligation to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized. These statements are subject to various risks, uncertainties and other factors that could cause actual results to ...

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