FDA re-authorizes Meridian Bioscience’s COVID-19 assay

Meridian Bioscience (Nasdaq:VIVO) announced today that the FDA re-authorized the emergency use authorization (EUA) for its COVID-19 test.

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 …

Read more
  • 0