FDA Clears First Test for Detecting CMV in Newborns

By PPN News Staff

The FDA cleared the Alethia CMV Molecular Amplification Test (Meridian Bioscience), a noninvasive test to detect congenital cytomegalovirus (cCMV) infection in newborns younger than 21 days of age.

CMV is the most common congenital infection and a leading cause of childhood cognitive deficits, hearing loss and visual impairments. According to the CDC, about one of every 200 infants is born with CMV infection.