VIVO - FDA re-authorizes emergency use approval for Meridian's Revogene COVID-19 test
- Meridian Bioscience ( NASDAQ: VIVO ) on Friday said the U.S. FDA had re-authorized its emergency use approval for the company's Revogene COVID-19 molecular diagnostic test.
- VIVO had initially received the emergency use nod in early Nov. last year.
- However, it was decided that the original design of the product, called the Revogene SARS-COV-2 molecular assay, would not detect the Omicron variant.
- Meridian ( VIVO ) then delayed marketing the test to modify the design to include for the detection of the variant.
- The FDA re-authorized the emergency use nod after reviewing data from additional clinical studies demonstrating the performance of the modified test.
- VIVO said it expects to begin shipping the Revogene COVID test before the end of its fiscal Q4.
- Meridian ( VIVO ) stock was slightly lower at the opening bell.
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FDA re-authorizes emergency use approval for Meridian's Revogene COVID-19 test