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

IndustryPRwire -- Meridian Bioscience announced that it has been awarded funding in the amount of approximately $1M by the National Institute of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) 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 RADxSM 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.

Dr. Lawrence Mertz, Senior Vice President, Diagnostics Research & Clinical Development Commented “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, We are now using this innovation to expand our respiratory viral menu on the Revogene® platform.”

The RADxSM 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 (RADxSM) 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.

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