Meridian Bioscience said it has resubmitted its application for emergency use authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the company’s SARS-CoV-2 molecular diagnostic test on the Revogene platform.
On February 22, 2021, Meridian voluntarily withdrew its EUA application, and said the company said it planned to conduct a new clinical validation study and a limit-of-detection bridging study, which it has now completed.
On February 16, 2021, the company received a written request from the FDA 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 had decided to withdraw the EUA application.
Revogene is an automated molecular platform with single and multiplex testing capabilities.
