FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

The U.S. Food and Drug Administration permitted marketing of a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus (CMV) in newborns less than 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.” According to the Centers for Disease Control and Prevention, more than half of adults by age 40 have been infected with CMV. Most people...