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FDA approves Meridian Bioscience's test for herpes in newborns

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

Meridian’s Alethia CMV Assay Test System detects cytomegalovirus (CMV) DNA from saliva swabs and won approval for use in babies younger than 21 days of age infected during pregnancy.

Over half of adults have been infected with CMV by the age of 40, according to the Centers for Disease Control and Prevention. Once the virus enters the body, it stays there for life and can reactivate.

 Most people affected show no signs or symptoms of infection, but those with weakened immune systems are susceptible and some babies can develop hearing problems or other long-term health problems, the FDA said here

“This test ...when used in conjunction with the results of other diagnostic tests, may help health care providers more quickly identify the virus in newborns and determine the best approach for the child,” said Tim Stenzel of the FDA’s Center for Devices and Radiological Health.

NOVEMBER 30, 2018


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