Meridian Bioscience submits application to FDA for Emergency Use Authorization for SARS-CoV-2 molecular assay

Rhea-AI Summary

Meridian Bioscience, Inc. (NASDAQ: VIVO) has applied for Emergency Use Authorization (EUA) from the FDA for its SARS-CoV-2 molecular diagnostic test on the Revogene® platform. This test offers qualitative detection of the virus responsible for COVID-19 with results available in as little as 47 minutes, enhancing testing capacity for healthcare providers. This marks a milestone for the Revogene platform and supports the company’s strategy to expand its respiratory diagnostics. The test is yet to receive FDA clearance or approval.

Positive

• Application for Emergency Use Authorization (EUA) submitted for the SARS-CoV-2 test.
• Results available in as little as 47 minutes, improving testing capacity.
• Significant milestone for the Revogene platform, signaling growth potential in respiratory diagnostics.
• Increased manufacturing capability supports expansion.

Negative

• The SARS-CoV-2 Molecular Diagnostic Test has not been FDA cleared or approved.

CINCINNATI, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Meridian Bioscience, Inc. (NASDAQ: VIVO), a provider of diagnostic testing solutions and life science raw materials, today announced that it has 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.

The SARS-CoV-2 test is a molecular diagnostic test for the qualitative detection of the SARS-CoV-2 virus, the causative agent of COVID-19. The COVID-19 global pandemic has resulted in a need for accurate and timely results to quickly determine which patients are infected with COVID-19. With results available as early as 47 minutes, the Revogene^® SARS-CoV-2 test will help customers improve their testing capacity and enable healthcare providers to quickly deliver appropriate care and guide infection control measures for patients. The Revogene^® is a flexible molecular testing platform that can be easily integrated into any laboratory or health system.

“As this is our first RNA based molecular assay, the Revogene^® SARS-CoV-2 test is a significant milestone for the Revogene platform and will open up additional opportunities to grow our respiratory franchise,” said Tony Serafini-Lamanna, Executive Vice President - Diagnostics. “With increased manufacturing capability, and assay performance supported by a good dataset, we believe this is the right COVID-19 assay to offer to our customers.”

For more information on the Revogene^® SARS-CoV-2 test, please visit https://www.meridianbioscience.com/human-condition/respiratory/coronavirus/revogene-sars-cov-2/.

The Revogene^® SARS-CoV-2 Molecular Diagnostic Test has not been FDA cleared or approved.

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 is Meridian Bioscience's latest announcement regarding VIVO?

Meridian Bioscience has submitted an application for Emergency Use Authorization (EUA) for its SARS-CoV-2 molecular diagnostic test.

How quickly can results be obtained from the new SARS-CoV-2 test by Meridian?

The Revogene® SARS-CoV-2 test provides results in as little as 47 minutes.

What are the implications of the EUA application for Meridian Bioscience's stock VIVO?

The EUA application represents a potential growth opportunity for Meridian, possibly positively impacting VIVO's stock value.

Has the SARS-CoV-2 test by Meridian received FDA approval?

No, the SARS-CoV-2 Molecular Diagnostic Test has not yet been FDA cleared or approved.