Meridian Bioscience receives U.S. FDA Emergency Use Authorization for Revogene SARS-CoV-2 molecular assay

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

Meridian Bioscience announced that their 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 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 predictive agreement (PPA) of 97.7% and a negative predicative agreement (NPA) of 97.7%.

The Revogene SARS-CoV-2 assay can help laboratories and healthcare systems improve their Covid-19 testing capacity and enable healthcare providers to quickly deliver the appropriate care and guide infection control measures for patients.  The flexible Revogene molecular testing platform can easily integrate into any laboratory or health system.