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Gene-based test for colorectal cancer approved by EU
Source: (cancerfacts.com)
Friday, January 08, 2010
DES PLAINES, Ill. – Jan. 8, 2010 (cancerfacts.com) – Abbott has announced it has received approval in the European Union for a new molecular diagnostic test for colorectal cancer.
The non-invasive, DNA-based blood test detects an activated form of Septin9, a gene linked to colorectal cancer. The Abbott 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 test for detecting the Septin 9 gene in blood and the first cancer assay available with Abbott's new advanced laboratory system.
"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 in a prepared statement.
"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," O'Kelly added.
Colorectal cancer originates from small, benign masses called polyps, which can become cancerous 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.
The new test, called RealTime mS9 Colorectal Cancer, assay 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 protein formation within the cell. Scientists have found that the methylation state of certain genes can be used as a biomarker for the transformation of a normal cell into 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, meaning only 10 percent of the samples were false positives, or incorrectly identified as cancer when they were not. By comparison, the fecal occult blood test identifies less than 50 percent of cancers.
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.
SOURCE: adapted from press materials provided by Abbott Laboratories
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