Magazin
2010-01-06
Des Plaines, Illinois (ots/PRNewswire) - Abbott announcedtoday it has received CE Marking (Conformite Europeene) in theEuropean Union for a new molecular diagnostic test, Abbott RealTimemS9 Colorectal Cancer, a non-invasive DNA assay that detects themethylated form of Septin 9, a gene linked to colorectal cancer, inblood specimens. The product is not available for sale in the UnitedStates.
The RealTime mS9 test will provide the physician with anothertool in determining whether a patient should be referred forcolonoscopy. It is the first automated assay for detecting the Septin9 gene in plasma and the first cancer assay available with Abbott'sm2000 PCR-based molecular diagnostic system.
Colorectal cancer is the third leading cause of cancer deathsworldwide, according to the World Health Organization. And, accordingto the Globocan 2002 database, there are an estimated 1 million newcases diagnosed every year. The disease originates from small, benignmasses called polyps, which can become malignant after several years.Physicians, therefore, advise regular colorectal cancer screeningtests after age 50 to all average risk individuals.
If detected early, the survival rate for colorectal cancerexceeds 90 percent. Unfortunately, more than half of all diagnosesoccur at late stages when the prognosis is usually poor. Patientcompliance with the fecal occult blood screening test on stoolsamples is low, the success rate is less than 50 percent andphysician acceptance and use of a more convenient blood test couldsignificantly increase the number of people being screened.
"A blood test for colorectal cancer is a significant diagnosticadvance that will increase compliance with screening and helpphysicians diagnose more patients at early stages when the diseasecan be treated most successfully," said Stafford O'Kelly, head ofAbbott's molecular diagnostics business. "Convenience has been amajor limitation of current colorectal cancer screening methods, andthe blood test addresses these long-standing concerns. If the testresult is positive, the patient can be referred for a colonoscopy toconfirm the finding and begin treatment."
Abbott RealTime mS9 Colorectal Cancer detects methylated DNA fromthe Septin 9 gene, which is shed into the bloodstream by colorectaltumors. DNA methylation is a biological process involved in celldivision and scientists have published data demonstrating that it isa biomarker for colorectal cancer. In several clinical studiesinvolving more than 3,000 samples, the new test detected 70 percentof cancers in all disease stages at 90 percent specificity.(Specificity refers to the probability that, given the absence ofdisease, a normal test result will exclude the disease.) Bycomparison, fecal occult blood tests, the only other non-invasivescreening method, identify less than 50 percent of malignancies.Colonoscopy is the most accurate colon cancer screening method, butthe high cost and patient reluctance to undergo this invasiveprocedure limits its utilization. The blood test offers a convenient,noninvasive method for identifying those patients for whomcolonoscopy is indicated.
The Abbott m2000 is a clinical real-time PCR diagnostic system.Widely used in laboratories worldwide, the system performs Abbott'sRealTime 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 inmolecular diagnostics - the analysis of DNA, RNA, and proteins at themolecular level. Abbott Molecular's instruments and reagents detectsubtle but key changes in patients' genes and chromosomes. Thesetests have the potential for earlier detection or diagnosis, caninfluence the selection of appropriate therapies and may improvemonitoring of disease progression.
About Abbott
Abbott is a global, broad-based health care company devoted tothe discovery, development, manufacture and marketing ofpharmaceuticals and medical products, including nutritionals, devicesand diagnostics. The company employs more than 72,000 people andmarkets its products in more than 130 countries.
Abbott's news releases and other information are available on thecompany's Web site at www.abbott.com.
ots Originaltext: Abbott LaboratoriesIm Internet recherchierbar: http://www.presseportal.de
Contact:CONTACT: Media, Don Braakman, +1-847-937-0080, or Financial, Tina Ventura,+1-847-935-9390, both of Abbott
New Abbott Gene-Based Test for Colorectal Cancer Receives CE Mark
Des Plaines, Illinois (ots/PRNewswire) - Abbott announcedtoday it has received CE Marking (Conformite Europeene) in theEuropean Union for a new molecular diagnostic test, Abbott RealTimemS9 Colorectal Cancer, a non-invasive DNA assay that detects themethylated form of Septin 9, a gene linked to colorectal cancer, inblood specimens. The product is not available for sale in the UnitedStates.
The RealTime mS9 test will provide the physician with anothertool in determining whether a patient should be referred forcolonoscopy. It is the first automated assay for detecting the Septin9 gene in plasma and the first cancer assay available with Abbott'sm2000 PCR-based molecular diagnostic system.
Colorectal cancer is the third leading cause of cancer deathsworldwide, according to the World Health Organization. And, accordingto the Globocan 2002 database, there are an estimated 1 million newcases diagnosed every year. The disease originates from small, benignmasses called polyps, which can become malignant after several years.Physicians, therefore, advise regular colorectal cancer screeningtests after age 50 to all average risk individuals.
If detected early, the survival rate for colorectal cancerexceeds 90 percent. Unfortunately, more than half of all diagnosesoccur at late stages when the prognosis is usually poor. Patientcompliance with the fecal occult blood screening test on stoolsamples is low, the success rate is less than 50 percent andphysician acceptance and use of a more convenient blood test couldsignificantly increase the number of people being screened.
"A blood test for colorectal cancer is a significant diagnosticadvance that will increase compliance with screening and helpphysicians diagnose more patients at early stages when the diseasecan be treated most successfully," said Stafford O'Kelly, head ofAbbott's molecular diagnostics business. "Convenience has been amajor limitation of current colorectal cancer screening methods, andthe blood test addresses these long-standing concerns. If the testresult is positive, the patient can be referred for a colonoscopy toconfirm the finding and begin treatment."
Abbott RealTime mS9 Colorectal Cancer detects methylated DNA fromthe Septin 9 gene, which is shed into the bloodstream by colorectaltumors. DNA methylation is a biological process involved in celldivision and scientists have published data demonstrating that it isa biomarker for colorectal cancer. In several clinical studiesinvolving more than 3,000 samples, the new test detected 70 percentof cancers in all disease stages at 90 percent specificity.(Specificity refers to the probability that, given the absence ofdisease, a normal test result will exclude the disease.) Bycomparison, fecal occult blood tests, the only other non-invasivescreening method, identify less than 50 percent of malignancies.Colonoscopy is the most accurate colon cancer screening method, butthe high cost and patient reluctance to undergo this invasiveprocedure limits its utilization. The blood test offers a convenient,noninvasive method for identifying those patients for whomcolonoscopy is indicated.
The Abbott m2000 is a clinical real-time PCR diagnostic system.Widely used in laboratories worldwide, the system performs Abbott'sRealTime 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 inmolecular diagnostics - the analysis of DNA, RNA, and proteins at themolecular level. Abbott Molecular's instruments and reagents detectsubtle but key changes in patients' genes and chromosomes. Thesetests have the potential for earlier detection or diagnosis, caninfluence the selection of appropriate therapies and may improvemonitoring of disease progression.
About Abbott
Abbott is a global, broad-based health care company devoted tothe discovery, development, manufacture and marketing ofpharmaceuticals and medical products, including nutritionals, devicesand diagnostics. The company employs more than 72,000 people andmarkets its products in more than 130 countries.
Abbott's news releases and other information are available on thecompany's Web site at www.abbott.com.
ots Originaltext: Abbott LaboratoriesIm Internet recherchierbar: http://www.presseportal.de
Contact:CONTACT: Media, Don Braakman, +1-847-937-0080, or Financial, Tina Ventura,+1-847-935-9390, both of Abbott
Abbott Laboratories Homepage ,Story,Pressemappe
