On Nov. 10, 2021, Meridian Bioscience announced that their Revogeneﾮ SARS-CoV-2 assay was granted Emergency Use Authorization by the U.S. Food and Drug Administration (FDA). Meridian expected to begin shipping this product before the end of its fiscal first quarter, ending December 31, 2021.

The Revogeneﾮ SARS-CoV-2 assay is a molecular diagnostic test for the qualitative detection of the SARS-CoV-2 virus, the causative agent of COVID-19. The test can return a positive result as soon as 47 minutes from nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swab specimens and provides impressive clinical performance with a positive percent agreement (PPA) of 97.7% and a negative percent agreement (NPA) of 97.7%.