Abbott announced it has received CE Mark in the European Union to market its RealTime PCR (Polymerase Chain Reaction) molecular diagnostic test for cytomegalovirus (CMV) 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 Centres for Disease Control and Prevention, each year in the United States,  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 pre-emptive 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.

“Molecular testing for CMV DNA is becoming the new standard because of its accuracy and precision in quantitating and monitoring CMV DNA — compared to serological tests. The automation of the m2000 system and the high reproducibility of the Abbott RealTime CMV assay, can provide rapid and reliable information to help clinicians make treatment decisions,” said Kristina Rodnikova, divisional vice president and general manager of Abbott's molecular diagnostics business in Europe.

The test is intended for use in conjunction with clinical presentation and other lab markers as an indicator to initiate therapy and as an aid in monitoring viral response to antiviral treatment. The test is not intended to be used as a screening test for CMV or as a diagnostic test to confirm the presence of CMV.

The new Abbott RealTime CMV assay is performed on the Abbott m2000 system, an automated instrument for DNA and RNA testing.

Abbott’s automated molecular diagnostics system, the m2000, utilizes real-time Polymerase Chain Reaction (PCR) technology for detecting and monitoring infectious diseases and is designed to provide clinical laboratories a unique system that fully automates all of the complex and heavily manual steps often associated with molecular diagnostics. With the availability of RealTime CMV, the Abbott m2000 system offers a broad menu of assays outside the United States, including tests for HIV-1 viral load, HIV-1 Qualitative, hepatitis B and C viral loads, hepatitis C genotyping, human papillomavirus, Epstein-Barr virus, chlamydia, chlamydia/gonorrhoea, colorectal cancer detection, and KIF6, a test to identify patients at risk for coronary heart disease. Tests approved in the United States are HIV-1 viral load, HBV viral load, HCV viral load, and chlamydia/gonorrhoea.

Abbott Molecular is a leader in molecular diagnostics — the analysis of DNA, RNA, and proteins at the molecular level. Abbott Molecular's tests can also detect subtle but key changes in patients' genes and chromosomes and have the potential for earlier detection or diagnosis, can influence the selection of appropriate therapies, and may improve monitoring of disease progression.

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.