DiaSorin received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Simplexa Congenital cytomegalovirus (CMV) Direct kit. This molecular diagnostic test enables direct detection of CMV DNA in both saliva swab and urine specimens from babies 21 days old or younger.

Saliva swab specimens are easy to collect for screening purposes and urine specimens are vital for confirmation. Simplexa Congenital CMV Direct is the first kit to receive FDA clearance for cytomegalovirus detection from both saliva swab and urine specimens. The assay is designed for use with the LIAISON MDX instrument.

Cytomegalovirus infection in otherwise healthy individuals is common and usually results in a mild, non-specific 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.

Congenital CMV is the most frequent infectious cause of neonatal malformation in developed nations. It is also the leading cause of non-genetic childhood hearing loss and a significant cause of neurodevelopmental delays that, if not diagnosed early, can lead to lifelong impairment. This makes fast and accurate diagnosis of congenital CMV critical for optimal disease management.

“The Simplexa Congenital CMV Direct kit is the first FDA-cleared product for diagnosing congenital CMV from both saliva swab and urine specimens,” says Michelle Tabb, chief scientific officer for DiaSorin Molecular. “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.”

Featured image: Cytomegalovirus CMV Infection in the Salivary Gland Viewed at 400x Magnification with Haemotoxylin and Eosin Staining. Photo: Dreamstime