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Feb. 23, 2021, 1:47 p.m. EST

Meridian Bioscience issues correction: It can't ship its Revogene SARS-CoV-2 test until EUA is granted

Meridian Bioscience Inc. (NAS:VIVO) issued a statement Tuesday afternoon, to correct a statement made earlier regarding its SARS-CoV-2 molecular diagnostic test on its Revogene platform. The stock dropped 8.7%, and has now tumbled 30.0% since it closed on Feb. 11 at the highest price since October 2008. After speaking with the Food and Drug Administration mid-morning Tuesday, the company said it will not be able to distribute its Revogene SARS-CoV-2 test until the test receives Emergency Use Authorization approval from the FDA. Earlier Tuesday, the company had said it would resume shipping of the tests once it notifies the FDA of its intent to re-submit an EUA application. The company said Tuesday that it had decided to withdraw its EUA application following further discussions with the FDA, which comes a week after the company said the FDA requested additional information on the test. Despite the recent selloff, Meridian's stock has still climbed 19.5% over the past three months, while the S&P 500 (S&P:SPX) has gained 7.7%.

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