The company added that the assay can help laboratories and healthcare systems improve their COVID-19 testing capacity, enabling providers to quickly deliver the appropriate care and guide infection control measures for patients through the use of Meridian’s flexible Revogene molecular testing platform that can integrate into any laboratory or health system.įiled Under: Diagnostics, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: coronavirus, COVID-19, Meridian Bioscience Inc. The test has demonstrated strong clinical performance with a positive predictive agreement (PPA) of 97.7% and a negative predicative agreement (NPA) of 97.7%, the company said. Meridian’s Revogene SARS-CoV-2 assay is a molecular diagnostic test for the qualitative detection of SARS-CoV-2 (the virus causing COVID-19) from nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swab specimens. Track your competitors, get freight forwarding leads, enforce exclusivity agreements, learn more.

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(NASDAQ: VIVO) is a fully integrated life science company that develops. US Customs Records Notifications available for Meridian Bioscience Inc., a supplier based in United States. “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.” Company Profile: Meridian Bioscience, Inc. “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,” Tony Serafini-Lamanna, EVP – diagnostics for Meridian Bioscience, said in the release. The company intends to begin shipping the product by the end of its fiscal fourth quarter on Sept. Following authorization, it was determined that the original design of the assay would not detect the Omicron variant, leading Meridian to delay marketing so it could modify the design to correctly detect the variant.Īccording to a news release, Meridian completed the development work and submitted an initial data set to the FDA to validate the performance of the redesigned assay in March, then completed additional clinical studies in order to garner re-authorization. is a fully integrated life science company, which engages in the development, manufacture, sale, and distribution of diagnostic. 10, 2021, for its Revogene SARS-CoV-2 assay. Meridian Bioscience (Nasdaq:VIVO) announced today that the FDA re-authorized the emergency use authorization (EUA) for its COVID-19 test.Ĭincinnati-based Meridian received EUA from the FDA on Nov.

Meridian bioscience