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Meridian Withdraws Emergency Use Authorization Application to FDA for Coronavirus MDx Test

This story has been updated to correct a company mistake. The firm had previously said it would continue marketing its COVID-19 test without FDA authorization.  

NEW YORK — Meridian Bioscience said on Tuesday that it has withdrawn its Emergency Use Authorization application to the US Food and Drug Administration for its Revogene SARS-CoV-2 test in order to conduct additional studies on the assay.

Last week, the Cincinnati-based company said that in response to its EUA application it had received a request for more information from the FDA about the PCR-based test, which uses nasopharyngeal swabs and is designed to provide results within 70 minutes.

Meridian's shares took a hit on that news, falling as much as 15 percent to $26.12 on the day of that announcement. In Tuesday afternoon trade on the Nasdaq, shares of Meridian slipped 9 percent to $20.92.

Meridian said it has now decided to pull the EUA application and, based on guidance from the FDA, conduct a new clinical validation study and limit-of-detection bridging study on the test.

Meridian said that it intends to resubmit the application as soon as possible following the completion of the studies, which are slated to begin before the end of March.

The company later released a clarification to its original statement, now saying it would not be able to distribute the test until it received EUA. Previously, it had said shipments of the test to customers were expected to resume during Meridian's fiscal third quarter, which ends on June 30.

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