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Medical Devices / Submissions and Approvals

FDA OK’s Test for Herpes Virus in Newborns

Dec. 4, 2018

The FDA has approved Meridian Bioscience’s diagnostic test for detecting cytomegalovirus (CMV), a type of herpes virus that occurs in newborns.

Most babies with CMV will show no signs or symptoms of infection, but some can develop hearing problems or other long-term health issues from the virus.

The test diagnoses CMV in newborns less than three weeks old by detecting virus DNA from a saliva swab.

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