DiaSorin Simplexa Congenital CMV Virus Direction Kit Cleared

DiaSorin’s Simplexa Congenital CMV Direct kit has received 510(k) clearance from the FDA for detection of cytomegalovirus DNA in both saliva and urine samples, the preferred specimens for newborns.

Although CMV infection in otherwise healthy individuals is common and usually results in mild illness, babies born with CMV can have brain, liver, spleen, lung and growth problems. The most common long-term health problem in babies is hearing loss, which can occur soon after birth or may develop later.

Intended for babies up to 21 days old, the diagnostic tests run on the company’s Liaison MDX polymerase chain reaction equipment.

The CMV kit, which gained a CE mark in June 2020, is the first to receive FDA clearance for both saliva and urine samples.