Meridian Bioscience Gets FDA Re-authorization Of EUA For Revogene SARS-CoV-2 Molecular Assay
(RTTNews) - Diagnostic testing provider Meridian Bioscience, Inc. (VIVO) announced Friday 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. Subsequent to that, it was determined that the original design of the assay would not detect the Omicron variant.
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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