预约演示
FDA re-authorizes Meridian Bioscience’s COVID-19 assay
2022-07-29
Cincinnati-based Meridian received EUA from the FDA on Nov. 10, 2021, for its Revogene SARS-CoV-2 assay. 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.
According 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.
The company intends to begin shipping the product by the end of its fiscal fourth quarter on Sept. 30, 2022.
“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. “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.”
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. 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.
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.
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