Meridian Bioscience has withdrawn its application with the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of its SARS-CoV-2 molecular test on the Revogene platform, according to a news release from the company.
Between now and the end of March 2021 and based on guidance from the FDA, Meridian said it plans to conduct a new clinical validation study and a limit-of-detection bridging study, with the intention of re-submitting an EUA application for its SARS-CoV-2 test on the Revogene platform.
The company received a written request from the FDA on February 16, 2021, asking for additional information about the Revogene SARS-CoV-2 test. After responding to that request and further discussions with FDA officials, Meridian said it decided to withdraw the EUA application.
Meridian had placed shipments of the SARS-CoV-2 test kits on hold February 16, 2021. Meridian will not be able to distribute the SARS-CoV-2 molecular diagnostic test on its Revogene platform until the test receives EUA approval from the FDA, the company said, citing a conversation with FDA officials.
