FDA authorizes Meridian Bioscience’s cytomegalovirus test

The U.S. Food and Drug Administration announced that it has permitted marketing of a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus in newborns less than 21 days of age. The Alethia CMV Assay Test System is used as an aid in the diagnosis of congenital CMV infection by detecting CMV deoxyribonucleic acid from a saliva swab. The FDA granted marketing authorization of the Alethia CMV Assay Test System to Meridian Bioscience.
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