Meridian Bioscience
Meridian Biosciences SARS-CoV-2 Molecular Test May Fail With Omicron Variant, FDA Says
The FDA noted that the test's failure is specific to Omicron, and its performance isn't affected by other SARS-CoV-2 variants.
The firm plans to submit at least three diagnostic assays to the FDA in the upcoming fiscal year, in addition to five life sciences products.
Meridian Bioscience Q4 Revenues Climb 19 Percent
The firm was boosted by a 22 percent increase in molecular assay revenues and a 14 percent increase in non-molecular test revenues.
Meridian Bioscience Nabs FDA EUA for Revogene SARS-CoV-2 Test
The authorization comes after the company rescinded its original submission to collect more data on the test.