Exhibit 99.1
For Immediate Release
Meridian Bioscience Provides a Further Update on the Revogene® SARS-CoV-2 EUA Submission
CINCINNATI, February 23, 2021 (GLOBE NEWSWIRE) – Meridian Bioscience, Inc. (NASDAQ: VIVO), a provider of diagnostic testing solutions and life science raw materials, provided a further update on 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.
Following the submission of Meridian’s written response to the FDA’s request for additional information on its Revogene® SARS-CoV-2 test on February 16, 2021 and further discussions with the FDA, on February 22, 2021, Meridian Bioscience elected to withdraw its EUA application. Between now and the end of March 2021 and based on guidance from the FDA, Meridian intends to conduct a new clinical validation study and a Limit-of-Detection bridging study, with the intention of re-submitting an EUA application for its SARS-CoV-2 test on the Revogene® platform as soon as possible thereafter. Upon notification to the FDA of its intent to re-submit an EUA application, during its third fiscal quarter, Meridian expects to resume shipping of this test to customers. Any change to our financial guidance will be discussed during our 2021 second fiscal quarter earnings call, scheduled for May 7, 2021, when we have more complete information.
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 differ materially, including, without limitation, the following: Meridian’s operating results, financial condition and continued growth depends, in part, on its ability to introduce into the marketplace enhancements of existing products or new products that incorporate technological advances, meet customer requirements and respond to products developed by Meridian’s competition, its ability to effectively sell such products and its ability to successfully expand and effectively manage increased sales and marketing operations. While Meridian has introduced a number of internally developed products and acquired products, there can be no assurance that it will be successful in the future in introducing such products on a timely basis or in protecting its intellectual property, and unexpected or costly manufacturing costs associated with its introduction of new products or acquired products could cause actual results to differ from expectations. Meridian relies on proprietary, patented and licensed technologies. As such, the Company’s ability to protect its intellectual property rights, as well as the potential for intellectual property litigation, would impact its results. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Recessionary pressures on the economy and the markets in which the Company’s customers operate, as well as adverse trends in buying patterns from customers, can change expected results. Costs and difficulties in complying with laws and
