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FDA Authorizes Marketing of Test for CMV in Newborns

FDA news release; 2018 Nov 30

The US Food and Drug Administration (FDA) has permitted marketing of a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus (CMV) in newborns aged <21 days. The FDA granted marketing authorization of the Alethia CMV Assay Test System to Meridian Bioscience, Inc., headquartered in Cincinnati, OH.

According to the Centers for Disease Control and Prevention (CDC), > half of adults by age 40 have been infected with CMV. Most people infected with CMV show no signs or symptoms of infection. However, CMV infection can cause serious health problems for people with weakened immune systems and for some newborns. Congenital CMV occurs when a baby is infected with CMV during pregnancy. Although most babies with CMV will not have any signs or symptoms of infection, some babies can develop hearing problems or other long-term health problems.

Administration: The Alethia CMV Assay Test System is used as an aid in the diagnosis of congenital CMV infection by detecting CMV deoxyribonucleic acid (DNA) from a saliva swab. Test results should be used only in conjunction with the results of other diagnostic tests and clinical information.


FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus. [news release]. Cincinnati, OH: Meridian Bioscience, Inc. November 30, 2018. Accessed December 5, 2018.