The German Federal Ministry of Education and Research is funding a project to assess the utility of Epigenomics’ mSEPT9 (methylated septin 9 gene) assay as a blood diagnostic for premalignant colorectal polyps. The roughly €1.3 million ($1.8 million) collaboration will also investigate the test for broader application, perhaps in combination with additional markers.
The real-time PCR-based mSEPT9 test is currently available as a research tool, and the biomarker is being evaluated in a multicenter, international prospective clinical study to determine its clinical utility in colorectal cancer detection. Epigenomics says clinical case-control studies on over 3,000 plasma samples from colorectal cancer patients, those with noncancerous colon diseases, and healthy controls have already shown detection of methylated septin 9 gene DNA in the blood provides sensitive and specific diagnosis of colorectal cancer?
Epigenomics has focused mSEPT9-based colorectal cancer diagnostic collaborations with Abbott, Quest Diagnostics, and most recently, Sysmex. Epigenomics and its first strategic partner for mSEPT9, Abbott Molecular, anticipate launching a CE-marked blood test in Europe in 2009, followed by regulatory filing for U.S. approval in 2010.
The current federally funded program comprises Epigenomics, the 2nd Medical Clinic of the University Hospitals rechts der Isar at the Munich Technical University, and the Association of Statutory Health Insurance Physicians in Bavaria.
“From a scientific and clinical point of view this research project is an innovative approach in cancer prevention,” comments Matthias Ebert, clinical study director at the 2nd Medical Clinical of the University of Hospital rechts der Isar of the Munich Technical University. “It focuses for the first time on screening for premalignant lesions, with the potential to catch the disease much earlier than current, noninvasive screening methods.”
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