NEW YORK – Meridian Bioscience announced on Monday that it has resubmitted its Revogene SARS-CoV-2 molecular diagnostic test to the US Food and Drug Administration for Emergency Use Authorization.
In February, the firm withdrew its application to conduct additional studies based on guidance from the agency, which had requested more information about the PCR-based test. As a result, the company decided to conduct a new clinical validation study and limit-of-detection bridging study on the test.
During its second fiscal quarter earnings call, CEO Jack Kenny said the firm conducted a study in March that showed a better limit of detection than the initial analysis.
The test uses nasopharyngeal swabs and is designed to provide results within 70 minutes.
Also in February, the firm received $5.5 million from the National Institute of Health's Rapid Acceleration of Diagnostics initiative to expand production capacity for the test. Kenny said on the earnings call that the expansion remained on track despite the withdrawal.
In early-morning trading on the Nasdaq, Meridian's stock price was up slightly to $21.01.