Meridian Bioscience receives NIH Award for supporting rapid development of Revogene® molecular test for SARS-CoV-2

Rhea-AI Summary

Meridian Bioscience (NASDAQ: VIVO) announced a $1M funding award from the NIH RADx initiative to expedite the launch of its SARS-CoV-2 molecular diagnostic test on the Revogene platform. The Emergency Use Authorization (EUA) application was submitted to the FDA on December 7. This funding will help develop a new assay consumable for detecting SARS-CoV-2 directly from viral transport media, optimizing clinical results. Meridian is among 47 projects advancing to Phase 1 for initial technology validation under the RADx initiative, aimed at accelerating COVID-19 testing innovation.

Positive

• Received $1M funding from the NIH RADx initiative.
• The funding supports the development of a new assay consumable for SARS-CoV-2 testing.
• Submitted EUA application to FDA for the Revogene SARS-CoV-2 assay.

Negative

• None.

CINCINNATI, Dec. 16, 2020 (GLOBE NEWSWIRE) -- Meridian Bioscience, Inc. (NASDAQ: VIVO), a provider of diagnostic testing solutions and life science raw materials, today announced that it has been awarded funding in the amount of approximately $1M by the National Institute of Health (NIH) Rapid Acceleration of Diagnostics (RADx^SM) initiative, to expedite the launch of the company’s SARS-CoV-2 molecular diagnostic test on the Revogene^® platform. On December 7, the application for Emergency Use Authorization (EUA) for the Revogene^® SARS-CoV-2 assay was submitted to the U.S. Food and Drug Administration (FDA).

NIH funds were critical to support the development of a new assay consumable for the Revogene^® platform enabling the detection of RNA targets, such as SARS-CoV-2 genomic RNA, directly from viral transport media without pre-dilution in the sample workflow. To achieve this goal, a new assay formulation was needed to not only optimize the microfluidic properties of our PIE assay device, but to also enable new enzymology and internal processing controls to ensure robust clinical results. The RADx^SM initiative further provided access to several experienced consultants and through the Center for Advancing Point of Care Technology (CAPCaT) program, gave us the ability to perform external clinical testing on our SARS-CoV-2 assay.

“The NIH contribution to our SARS-CoV-2 assay was instrumental in our goal achievement, providing a kick-start to meet our product development milestones and helping us create a new generation PIE device for the detection of respiratory viral targets directly from unprocessed specimens,” said Dr. Lawrence Mertz, Senior Vice President, Diagnostics Research & Clinical Development. “We are now using this innovation to expand our respiratory viral menu on the Revogene^® platform.”

The RADx^SM initiative was launched by NIH to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. Meridian Bioscience is one of forty-seven projects that made the cut and moved to Phase 1, a rigorous four to six-week period of initial technology validation. 

This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADx^SM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Heart, Lung and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Federal Award Number U54HL143541.

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

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

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 funding did Meridian Bioscience receive?

Meridian Bioscience received $1M from the NIH RADx initiative to support its SARS-CoV-2 diagnostic test development.

When did Meridian submit the EUA application for the Revogene SARS-CoV-2 assay?

Meridian submitted the EUA application to the FDA on December 7.

What is the purpose of the NIH RADx initiative?

The NIH RADx initiative aims to accelerate the development and implementation of COVID-19 testing technologies.

What platform is the SARS-CoV-2 test being developed for?

The SARS-CoV-2 test is being developed for the Revogene platform.

What does the NIH funding support in the development of the SARS-CoV-2 assay?

The funding supports the creation of a new assay consumable for direct detection of SARS-CoV-2 from viral transport media.