FDA Nod For First Test To Detect Herpes Virus In Newborns

(RTTNews) - The first test to aid in detecting cytomegalovirus, a type of herpes virus, in newborns has received the FDA go-ahead.

Developed by Meridian Bioscience Inc. (VIVO), the device, which goes by the name Alethia CMV Assay Test System, detects CMV deoxyribonucleic acid from a saliva swab of newborns less than three weeks of age.

About 1 out of every 200 babies is born with congenital cytomegalovirus (CMV), and about 1 out of 5 of these babies will have birth defects or other long-term health problems, according to the CDC.

Commenting on the FDA authorization, Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said, "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."

VIVO closed Monday's trading at $19.18, up 1.27%.