Meridian Bioscience, Inc. (NASDAQ: VIVO), a provider of diagnostic testing solutions and life science raw materials, today 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. 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 high demand for fast, accurate detection of COVID-19 especially considering the upcoming respiratory season and combating the COVID-19 variants that continue to emerge," said 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."

To learn more about the Revogene® SARS-CoV-2 assay, please visit https://www.meridianbioscience.com/revogene-sars-cov-2/. For sales inquiries, please contact Meridian Bioscience at 1-888-763-6769 or [email protected].