UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
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Emerging growth company
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Item 7.01. | Regulation FD Disclosure. |
On June 28, 2021, Meridian Bioscience, Inc. (the “Company”) issued a press release announcing its resubmission of its application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the Company’s SARS-CoV-2 molecular diagnostic test on the Revogene® platform. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information in Item 7.01 of this Form 8-K and in the press release attached as Exhibit 99.1 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in Item 7.01 of this Form 8-K and Exhibit 99.1 shall not be incorporated by reference in any filing (whether made before or after the date hereof) or any other document under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in any such filing or document. The furnishing of the information contained in Item 7.01 (including Exhibit 99.1) is not intended to, and does not, constitute a determination or admission by the Company that this information is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company.
Item 9.01. | Financial Statements and Exhibits. |
(d) | Exhibits |
99.1 | Press Release dated June 28, 2021 | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
MERIDIAN BIOSCIENCE, INC. | ||||||
Date: June 28, 2021 | By: /s/ Bryan T. Baldasare | |||||
Executive Vice President and Chief Financial Officer | ||||||
(Principal Financial and Accounting Officer) |
Exhibit 99.1
For Immediate Release
Meridian Resubmits Application to FDA for Emergency Use Authorization for Revogene® SARS-CoV-2 Molecular Assay
CINCINNATI, OHIO June 28, 2021 (GLOBE NEWSWIRE) Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, announced today that it has re-submitted its application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the companys SARS-CoV-2 molecular diagnostic test on the Revogene® platform.
On February 22, 2021, Meridian voluntarily withdrew its EUA application in order to conduct additional studies based on guidance from the FDA. Meridian completed the additional studies and re-submitted its EUA application on Friday, June 25, 2021.
Tony Serafini-Lamanna, Executive Vice President Diagnostics, said, We are pleased to have completed these studies and resubmitted our EUA application. We look forward to the FDAs review of the Revogene SARS-CoV-2 assay.
About Meridian Bioscience, Inc.
Meridian is a fully integrated life science company that develops, manufactures, markets, and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy, and simplicity that are redefining the possibilities of life from discovery to diagnosis. Through discovery and development, we provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, we provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. We build relationships and provide solutions to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers, and biotech companies in more than 70 countries around the world.
Meridians shares are traded on the NASDAQ Global Select Market, symbol VIVO. Meridians website address is www.meridianbioscience.com.
Contact:
Charlie Wood
Vice President Investor Relations
Meridian Bioscience, Inc.
Phone: +1 513.271.3700
Email: mbi@meridianbioscience.com
###
Document and Entity Information |
Jun. 28, 2021 |
---|---|
Cover [Abstract] | |
Entity Registrant Name | MERIDIAN BIOSCIENCE INC |
Amendment Flag | false |
Entity Central Index Key | 0000794172 |
Document Type | 8-K |
Document Period End Date | Jun. 28, 2021 |
Entity Incorporation State Country Code | OH |
Entity File Number | 0-14902 |
Entity Tax Identification Number | 31-0888197 |
Entity Address, Address Line One | 3471 River Hills Drive |
Entity Address, City or Town | Cincinnati |
Entity Address, State or Province | OH |
Entity Address, Postal Zip Code | 45244 |
City Area Code | (513) |
Local Phone Number | 271-3700 |
Written Communications | false |
Soliciting Material | false |
Pre Commencement Tender Offer | false |
Pre Commencement Issuer Tender Offer | false |
Security 12b Title | Common Stock, no par value |
Trading Symbol | VIVO |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | false |
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