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DiaSorin Gets FDA 510(k) Clearance for Molecular CMV Test

NEW YORK — Italian diagnostics firm DiaSorin said on Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for its Simplexa Congenital CMV Direct kit for the detection of cytomegalovirus (CMV) DNA.

Congenital CMV occurs when the virus is passed from mother to child, resulting in potentially fatal outcomes. The test, which runs on DiaSorin's Liaison MDx instrument, is designed to detect CMV DNA in both saliva swab and urine specimens from newborns 21 days old or younger.

"The Simplexa Congenital CMV Direct kit is the first FDA-cleared product for diagnosing congenital CMV from both saliva swab and urine specimens," DiaSorin CSO Michelle Tabb said in a statement. "This allows accurate and fast diagnosis with one test enabling early intervention and treatment."

The test received CE marking in mid-2020.