FDA has approved the marketing of test to detect cytomegalovirus (CMV), a type of herpes virus in neonates below 21 days of age. “Although most people who become infected with cytomegalovirus face little to no risk of serious illness, the virus has the potential to cause serious illness for people with weak immune systems and in newborn babies,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
“This test for detecting the virus, 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.” CMV infection can cause severe health problems in immunosuppressed people as well as newborns whose immune systems are yet underdeveloped. Congenital CMV occurs when a baby is…
