Meridian Bioscience Gets Emergency Nod In U.S. For Revogene SARS-CoV-2 Molecular Assay

(RTTNews) - Meridian Bioscience Inc.'s (VIVO) Revogene SARS-CoV-2 assay was granted Emergency Use Authorization by the U.S. Food and Drug Administration, the company said in a statement.

The company expects to begin shipping the 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 company noted that 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%.