Abbott Gets Ce Mark For Realtime Molecular Test For Cyto

Abbott ABT announced it has received CE Mark in the European Union to market its RealTime PCR (polymerase chain reaction) molecular diagnostic test for cytomegalovirus DNA quantitation in human plasma or whole blood. Approximately eighty percent of healthy adults over 40 carry the ubiquitous virus, which has life-long latency, can be reactivated periodically, and cause mild, flu-like symptoms. However, in infants and immune-compromised patients, CMV reactivation can cause serious, possibly life-threatening complications. Congenital CMV infection, for example, is the leading viral cause of hearing loss and mental disability in newborns. According to the Centers for Disease Control and Prevention, each year in the United States, 1 in 750 children are born with or develop permanent health problems from congenital CMV infection. It is responsible for more childhood disabilities than better known congenital syndromes, such as spina bifida, fetal alcohol syndrome and Down's syndrome. CMV is the most common viral infection in organ and stem cell transplant recipients and can also lead to severe complications in AIDS patients and others who are immunocompromised. Without prophylactic or preemptive treatment against CMV with antiviral drugs, the virus can cause post-transplantation rejection, as well as opportunistic infections. Monitoring for CMV infection in conjunction with antiviral medication when appropriate can reduce mortality and morbidity, and increase transplant success rates.