CMV Saliva Test Approved by FDA

Meridian Bioscience has received U.S. Food and Drug Administration (FDA) clearance for its new Alethia CMV Molecular Amplification Test (formerly, the Illumigene brand). The assay is designed to specifically detect congenital Cytomegalovirus (cCMV) infection in newborns from an easy-to-collect saliva sample. It is the first qualitative test in a molecular amplification format that is cleared by FDA for cCMV testing in newborns.

The most common congenital infection, cCMV is a leading cause of childhood hearing loss, cognitive deficits and visual impairment. According to the Centers for Disease Control and Prevention, approximately one in 200 babies are born with cCMV infection, and approximately 10 percent to 25 percent of all childhood sensorial hearing loss can be attributed to cCMV. Babies are at risk of infection during pregnancy if the virus in the mother’s blood crosses through the placenta. Early detection is critical in establishing appropriate treatment. Diagnosis can be attained by detecting the virus in a baby’s saliva or urine within two to three weeks from birth.

“Unfortunately cCMV infection is more common than other newborn-related illnesses, like group B strep for example, yet the level of awareness is considerably lower,” said Jack Kenny, chief executive officer. “With Alethia CMV, we not only look to increase awareness, but also provide laboratories with an FDA-cleared test that they can use with confidence when diagnosing newborns with cCMV. Alethia CMV helps meet a critical need with a simple-to-collect saliva sample in combination with a procedurally simple, rapid and sensitive test.”