Meridian Bioscience, Inc. 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 percent agreement (PPA) of 97.7% and a negative percent 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.”
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. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. 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 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3 (b)(1), unless the declaration is terminated, or authorization is revoked sooner.