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

08 Jan 2010 - Abbott announced it has received CE Marking (Conformité Européene) 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.
 
"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."