Meridian Bioscience, Inc. (NASDAQ: VIVO), a leading global provider of diagnostic testing solutions and life science raw materials, announced that it received re-authorization of its Emergency Use Authorization (EUA) for the Revogene® SARS-COV-2 molecular assay from the U.S. Food and Drug Administration (FDA). Meridian expects to begin shipping this product before the end of its fiscal fourth quarter, ending September 30, 2022.
On November 10, 2021, Meridian announced the Revogene® SARS-CoV-2 assay was granted authorization by the FDA. After that, it was determined that the original design of the assay would not detect the Omicron variant and Meridian delayed marketing the assay to modify its design to correct for the detection of the variant. In March, Meridian completed the development work and submitted an initial set of data to the FDA to validate the performance of this revised assay. Over the last few months in consultation with the FDA, Meridian completed additional clinical studies and the FDA has now re-authorized the EUA.
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