Meridian Bioscience receives FDA emergency use authorization SARS-CoV-2 molecular assay

Nov. 12, 2021

Meridian Bioscience said its Revogene SARS-CoV-2 assay was granted emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA).

Meridian expects to begin shipping this product before the end of its fiscal first quarter, ending December 31, 2021.

The Revogene SARS-CoV-2 assay is a molecular diagnostic test for the qualitative detection of the SARS-CoV-2 virus. 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 a positive percent agreement (PPA) of 97.7% and a negative percent agreement (NPA) of 97.7%.

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