Meridian Bioscience Pulls Out Revogene COVID-19 Test EUA Application

By nafricx on February 23, 2021

After submitting a written response to the FDA’s request for additional information on Meridian Bioscience Inc’s (NASDAQ: VIVO) Revogene SARS-CoV-2 test on February 16 and further discussions with the FDA, the company decided to withdraw its Emergency Use Authorization (EUA) application.
The company plans to conduct a new clinical validation study and a Limit-of-Detection bridging study, with potential re-submission of a EUA application during Q3 of 2021.
Price Action: VIVO is down 3.39% at $22.23 on the last check Tuesday.