Abbott Receives CE Mark for its RealTime Molecular Test for CytomegalovirusBy Abbott, PRNE
Tuesday, May 24, 2011
WIESBADEN, Germany, May 25, 2011 -
Abbott (NYSE: ABT) 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
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
"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.
About the Abbott m2000 System
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/gonorrhea,
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/gonorrhea.
About Abbott Molecular
Abbott Molecular, www.abbottmolecular.com, 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. The
company employs nearly 90,000 people and markets its products in more than
Abbott's new releases and other information are available on the
company's Web site at www.abbott.com.
Media, Cheryl Dodd of Abbott, +1-847-937-6570
Tags: Abbott, Germany, May 25, Western Europe, Wiesbaden