DiaSorin congenital CMV direct assay receives FDA 510(k) clearance

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Saluggia, Italy-based DiaSorin on Wednesday announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Simplexa Congenital CMV Direct kit.

The molecular diagnostic test enables direct detection of cytomegalovirus (CMV) DNA in saliva swab and urine specimens from babies 21 days old or younger.

CMV infection in otherwise-healthy individuals is common and usually results in a mild, nonspecific illness. However, congenital CMV, which occurs when the virus is passed from mother to unborn baby, can lead to dangerous, even fatal outcomes. Many healthcare organizations globally are considering the need for universal CMV screening programs for newborns. Saliva swab specimens are easy to collect for screening purposes and urine specimens are vital for confirmation, DiaSorin noted.

The cleared assay is designed for use with the firm’s Liaison MDX instrument.

“The Simplexa Congenital CMV Direct kit is the first FDA-cleared product for diagnosing congenital CMV from both saliva swab and urine specimens,” Michelle Tabb, chief scientific officer for DiaSorin Molecular, said in a statement. “Claims for both sample types allows users to follow [Centers for Disease Control and Prevention] recommendations with the simplified workflow of Simplexa. This allows accurate and fast diagnosis with one test enabling early intervention and treatment.”

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