New Abbott Gene-Based Test for Colorectal Cancer Receives CE Mark

By Abbott, PRNE
Tuesday, January 5, 2010

DES PLAINES, Illinois, January 6 - Abbott (NYSE: ABT) 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 States.

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.

About Abbott

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.

Media, Don Braakman, +1-847-937-0080, or Financial, Tina Ventura, +1-847-935-9390, both of Abbott

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Discussion

alice
January 6, 2010: 3:39 pm

” Women with breast cancer treated with chemotherapy and after that with Tamoxifen had about 20% improvement in disease-free survival compared to women treated with tamoxifen only. ” (www.isrameds.com news cancer)

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