November 30, 2018 / 9:08 PM / 11 days ago

FDA approves Meridian Bioscience's diagnostic for herpes in newborns

Nov 30 (Reuters) - The U.S. Food and Drug Administration approved on Friday a diagnostic test from Meridian Bioscience Inc as the first tool to help detect a type of herpes virus in newborns.

Meridian’s Alethia CMV Assay Test System won approval to detect cytomegalovirus (CMV) in babies younger than 21 days of age.

While most people affected with CMV show no signs or symptoms of infection, some babies can develop hearing problems or other long-term health problems, the FDA said here. (Reporting by Tamara Mathias in Bengaluru: Editing by Sriraj Kalluvila)

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