FDA Clears Meridian Bioscience's Newborn Cytomegalovirus Test

NEW YORK (GenomeWeb) – The US Food and Drug Administration announced on Friday it has completed the de novo premarket review and cleared for marketing Meridian Bioscience's cytomegalovirus assay for newborns called the Alethia CMV Assay Test System.

The Alethia brand is the new name for Meridian's molecular test line, which was previously marketed under the Illumigene and Illumipro names.