Des Plaines, Illinois (ots/PRNewswire) - Abbott announced
today it has received CE Marking (Conformite Europeene) in the
European Union for a new molecular diagnostic test, Abbott RealTime
mS9 Colorectal Cancer, a non-invasive DNA assay that detects the
methylated form of Septin 9, a gene linked to colorectal cancer, in
blood specimens. The product is not available for sale in the United
The RealTime mS9 test will provide the physician with another
tool in determining whether a patient should be referred for
colonoscopy. It is the first automated assay for detecting the Septin
9 gene in plasma and the first cancer assay available with Abbott's
m2000 PCR-based molecular diagnostic system.
Colorectal cancer is the third leading cause of cancer deaths
worldwide, according to the World Health Organization. And, according
to the Globocan 2002 database, there are an estimated 1 million new
cases diagnosed every year. The disease originates from small, benign
masses called polyps, which can become malignant after several years.
Physicians, therefore, advise regular colorectal cancer screening
tests after age 50 to all average risk individuals.
If detected early, the survival rate for colorectal cancer
exceeds 90 percent. Unfortunately, more than half of all diagnoses
occur at late stages when the prognosis is usually poor. Patient
compliance with the fecal occult blood screening test on stool
samples is low, the success rate is less than 50 percent and
physician acceptance and use of a more convenient blood test could
significantly increase the number of people being screened.
"A blood test for colorectal cancer is a significant diagnostic
advance that will increase compliance with screening and help
physicians diagnose more patients at early stages when the disease
can be treated most successfully," said Stafford O'Kelly, head of
Abbott's molecular diagnostics business. "Convenience has been a
major limitation of current colorectal cancer screening methods, and
the blood test addresses these long-standing concerns. If the test
result is positive, the patient can be referred for a colonoscopy to
confirm the finding and begin treatment."
Abbott RealTime mS9 Colorectal Cancer detects methylated DNA from
the Septin 9 gene, which is shed into the bloodstream by colorectal
tumors. DNA methylation is a biological process involved in cell
division and scientists have published data demonstrating that it is
a biomarker for colorectal cancer. In several clinical studies
involving more than 3,000 samples, the new test detected 70 percent
of cancers in all disease stages at 90 percent specificity.
(Specificity refers to the probability that, given the absence of
disease, a normal test result will exclude the disease.) By
comparison, fecal occult blood tests, the only other non-invasive
screening method, identify less than 50 percent of malignancies.
Colonoscopy is the most accurate colon cancer screening method, but
the high cost and patient reluctance to undergo this invasive
procedure limits its utilization. The blood test offers a convenient,
noninvasive method for identifying those patients for whom
colonoscopy is indicated.
The Abbott m2000 is a clinical real-time PCR diagnostic system.
Widely used in laboratories worldwide, the system performs Abbott's
RealTime molecular diagnostic assays for HIV, hepatitis B and C,
chlamydia, gonorrhea and human papillomavirus.
About Abbott Molecular
Abbott Molecular, abbottmolecular.com, is an emerging leader in
molecular diagnostics - the analysis of DNA, RNA, and proteins at the
molecular level. Abbott Molecular's instruments and reagents detect
subtle but key changes in patients' genes and chromosomes. These
tests 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 more than 72,000 people and
markets its products in more than 130 countries.
Abbott's news releases and other information are available on the
company's Web site at www.abbott.com.
ots Originaltext: Abbott Laboratories
Im Internet recherchierbar: http://www.presseportal.ch
CONTACT: Media, Don Braakman, +1-847-937-0080, or Financial, Tina
Ventura,+1-847-935-9390, both of Abbott