NEW YORK — DiaSorin Molecular said on Monday that it has received CE marking for its Simplexa Congenital CMV Direct kit for the detection of cytomegalovirus (CMV) DNA.
According to DiaSorin Molecular, Congenital CMV, which occurs when the virus is passed from mother to an unborn child, can led to severe and potentially fatal outcomes. Approximately 60,000 children are born each year in the US and EU with the infection, it said.