Meridian Bioscience, a global provider of diagnostic testing solutions and life science raw materials, received re-authorization of its Emergency Use Authorization (EUA) for the Revogene SARS-COV-2 molecular assay from the U.S. Food and Drug Administration (FDA). 

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

On Nov. 10, 2021, Meridian announced the Revogene SARS-CoV-2 assay was granted authorization by the FDA.  It was subsequently determined that the original design of the assay would not detect the Omicron variant to which 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 this 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.

The Revogene Assay

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 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 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.  Additional FDA-approved tests on the Revogene platform include Revogene C. difficile, Revogene Strep A, Revogene GBS LB, and Revogene Carba C.

“There continues to be demand for fast, accurate detection of COVID-19 especially considering the high transmissibility of these new variants and the upcoming respiratory season,” says Tony Serafini-Lamanna, executive vice president – diagnostics for Meridian Bioscience.  “We believe our Revogene SARS-CoV-2 assay and growing Revogene platform can help clinicians and health systems meet these demands now and in the future.”

This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.  The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19.