Meridian Bioscience Receives Re-Authorization from FDA for its Revogene® SARS-CoV-2 Molecular Assay
CINCINNATI, July 29, 2022 /PRNewswire/ -- Meridian Bioscience, Inc. (NASDAQ: VIVO), a leading global provider of diagnostic testing solutions and life science raw materials, announced that it 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 September 30, 2022.
On November 10, 2021, Meridian announced the Revogene® SARS-CoV-2 assay was granted authorization by the FDA. Subsequent to that, it was determined that the original design of the assay would not detect the Omicron variant and 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® 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 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 demand for fast, accurate detection of COVID-19 especially considering the high transmissibility of these new variants and the upcoming respiratory season," 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 firstname.lastname@example.org.
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.
About Meridian Bioscience, Inc.
Meridian's shares are traded on the NASDAQ Global Select Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
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SOURCE Meridian Bioscience, Inc.
Company Codes: NASDAQ-NMS:VIVO