Meridian Bioscience said Wednesday it initiated clinical trials for an illumigene congenital Cytomegalovirus (CMV) molecular amplification test, after enrolling an international team of global experts in neonatal CMV infections to support the studies. Shares drifted marginally higher intraday.
The assay is designed to specifically detect the CMV infection in newborns from saliva, the company said in a statement.
Presently, there is no Food and Drugs Administration-cleared test for CMV screening in newborns. The company said congenital CMV can be diagnosed if the virus is detected in a baby’s urine or saliva, within 2 to 3 weeks from birth. It noted legislation has been passed or is under consideration in numerous states regarding CMV education and testing in neonates.