By IDSE 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.
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The Alethia CMV assay is used as an aid in the diagnosis