DiaSorin has secured the US Food and Drug Administration (FDA) 510(k) clearance for its Simplexa Congenital CMV Direct molecular diagnostic test.
According to the Italy-based biotechnology company, the test is designed to directly detect cytomegalovirus (CMV) DNA in saliva swabs as well as urine specimens from infants, aged 21 days old or younger.
DiaSorin said that urine samples are necessary for confirmation while saliva swab samples are simple to gather for screening.
The biotechnology firm claimed that Simplexa Congenital CMV Direct is the first kit to get FDA approval for CMV direct detection from both saliva swabs and urine specimens.
The test is intended for use with the LIAISON MDX instrument and is operated via the Direct Amplification Disc (DAD) for rapid detection.
DiaSorin molecular chief scientific officer Michelle Tabb said: “The Simplexa Congenital CMV Direct kit is the first FDA-cleared product for diagnosing congenital CMV from both saliva swab and urine specimens.
“Claims for both sample types allows users to follow CDC recommendations with the simplified workflow of Simplexa. This allows accurate and fast diagnosis with one test enabling early intervention and treatment. We are excited to offer this valuable test as part of our growing menu.”
DiaSorin serves the In Vitro Diagnostic (IVD) field across five continents through 43 companies, four branches, nine research and development centres, and 10 manufacturing facilities.
In November 2021, the Italian biotech company along with QIAGEN received approval from the FDA for use of QuantiFERON-TB Gold Plus assay on the automated LIAISON XS platform.
