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.
The kit uses either saliva or urine specimens from infants up to 21 days old and runs on the Cypress, California-based company's Liaison MDX RT-PCR instrument.
DiaSorin Molecular is a unit of Saluggia, Italy-based DiaSorin.