Meridian Obtains Re-Authorization From FDA For Revogene SARS-CoV-2 Molecular Assay

(RTTNews) - Meridian Bioscience Inc. (VIVO) said Friday that it received re-authorization of its Emergency Use Authorization for the Revogene SARS-COV-2 molecular assay from the U.S. Food and Drug Administration.

Meridian expects to begin shipping the product before the end of its fiscal fourth quarter, ending September 30, 2022.

The Revogene SARS-CoV-2 assay is a molecular diagnostic test for the qualitative detection of the SARS-CoV-2 virus from nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swab specimens and provides impressive clinical performance with a positive predictive agreement (PPA) of 97.7% and a negative predicative agreement (NPA) of 97.7%, Meridian said in a statement.

In 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 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 the 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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