Meridian Resubmits Application to FDA for Emergency Use Authorization for Revogene® SARS-CoV-2 Molecular Assay

Rhea-AI Summary

Meridian Bioscience has re-submitted its Emergency Use Authorization (EUA) application to the FDA for its SARS-CoV-2 molecular diagnostic test on the Revogene platform. This follows the voluntary withdrawal of their previous application on February 22, 2021, to conduct further studies as advised by the FDA. The new application was re-submitted on June 25, 2021. Executive Vice President Tony Serafini-Lamanna expressed optimism regarding the FDA's forthcoming review of the Revogene SARS-CoV-2 assay.

Positive

• Re-submission of EUA application may expedite approval process for the Revogene SARS-CoV-2 diagnostic test.
• Completion of additional studies as per FDA guidance enhances credibility and compliance.

Negative

• Previous withdrawal of EUA application may raise concerns about the test's reliability or efficacy.

CINCINNATI, 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 company’s 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 FDA’s 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.

Meridian’s shares are traded on the NASDAQ Global Select Market, symbol VIVO. Meridian’s 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

FAQ

What recent action did Meridian Bioscience take regarding its EUA application for VIVO?

Meridian Bioscience re-submitted its Emergency Use Authorization application for the SARS-CoV-2 test on June 25, 2021, after completing additional required studies.

Why did Meridian withdraw its EUA application initially for VIVO?

The EUA application was voluntarily withdrawn on February 22, 2021, to conduct additional studies based on FDA guidance.

What is the significance of the Revogene platform for Meridian Bioscience?

The Revogene platform is designed for molecular diagnostics, including the recently submitted SARS-CoV-2 test, which aims to enhance testing efficiency.

How did Meridian's recent actions affect its stock symbol VIVO?

The re-submission of the EUA application could positively influence investor sentiment around the stock symbol VIVO, depending on FDA outcomes.