Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnostics company, reports that Dr. Uri Ladabaum, Associate Professor in the Department of Gastroenterology and Hepatology at the School of Medicine of Stanford University (Redwood City, CA, U.S.A.), has presented the results of a health economic analysis of potential future colorectal cancer screening with Septin9 blood tests at the ongoing Digestive Disease Week 2011. Septin9 tests detect cell-free DNA derived from tumors in the colon and rectum in the blood stream by means of a DNA methylation pattern in the SEPT9 gene that is specific for colorectal cancer. The biomarker and detection technologies used in Septin9 testing are proprietary to Epigenomics.
Using a validated Markov model for colorectal cancer screening reflecting U.S. colorectal cancer epidemiology and health care cost structure, Dr. Ladabaum and coworkers compared Septin9 testing to current standard methods of colorectal cancer screening, i.e. fecal occult blood testing (FOBT), fecal immunochemical testing (FIT), sigmoidoscopy and colonoscopy.
Their analysis is based on clinical performance data for Septin9 testing from a prospective trial with over 7,900 average-risk screening guideline-eligible subjects, previously reported at Digestive Disease Week in 2010. In this study, a first generation Septin9 test detected up to 67% of the cancer cases at 88% specificity.
The analysis demonstrates that at the population level, Septin9 testing yielded the greatest incremental benefit at acceptable costs when it increases the fraction of the population screened. The group concluded that screening for colorectal cancer using Septin9 tests is a medically beneficial and health economically cost-effective strategy when it addresses the currently unscreened population in the U.S.
Patient behavior studies to understand screening barriers in unscreened individuals and the potential impact of a blood test as an alternative option for screening are ongoing at the University of Utah and the Huntsman Cancer Institute in collaboration with ARUP Laboratories, Salt Lake City, UT, U.S.A. First results from focus groups, recently presented by Jennifer Taber, M.S., of the Department of Psychology at the University of Utah at the 2011 Annual Meeting of the American Society of Preventive Oncology, indicated that the majority of the currently unscreened patients would take a Septin9 test for screening. No significant differences with regard to gender, religion, marital status, health care coverage or ethnicity were observed. Going forward, a quantitative survey and a prospective longitudinal clinical study are planned to further investigate the impact of blood tests on patient acceptance of colorectal cancer screening and their potential to increase overall screening compliance.
Jennifer Taber remarked: "The initial results suggest that community members are interested in Septin9 testing in part because of its high accuracy and the convenient and noninvasive aspects of the procedure. Going forward, we hope to learn whether blood-based tests will increase colorectal cancer screening rates by reducing the currently existing barriers."
Dr. Philip Schoenfeld, M.D., M.Sc., M.Sc., Associate Professor of Medicine, Division of Gastroenterology at the University of Michigan School of Medicine and member of Epigenomics' Medical Advisory Board commented on the two studies: "The cost effectiveness and patient behavior studies are important additions to the clinical utility study completed last year for Septin9. These are essential steps to support physician and payer acceptance of Septin9 testing, and its potential to improve patient access to colorectal cancer screening approaches with clear clinical benefit."
Under licenses by Epigenomics, Septin9 testing is currently offered in the U.S. by Quest Diagnostics (ColoVantage™) and ARUP Laboratories (Methylated Septin9 Test) based on laboratory-developed tests aiding in the detection of colorectal cancer. Epigenomics and its partner Abbott already market their respective first generation CE-marked Septin9 tests in Europe, the Middle East, Asia/Pacific and further markets. Epigenomics is in the process of developing a second generation Septin9 assay as a colorectal cancer screening test for the U.S. and European market. Epigenomics expects to submit this enhanced Septin9 test branded Epi proColon® 2.0 to the FDA for regulatory review and pre-market approval as a colorectal cancer screening test before year-end 2011.
Dr. Juergen Beck, M.D., Epigenomics' Senior Vice President of Medical Affairs commented: "Dr. Ladabaum and his colleagues have undertaken a thorough and stringent analysis. The results of the study confirm our own expectations on the medical benefit and cost-effectiveness of Septin9 testing and are in line with a future positioning as an additional screening option for those people currently reluctant to undergo screening by available conventional methods. Our emphasis in clinical research now lies on demonstrating the required compliance benefit of Septin9 blood tests and we are looking forward to further results of the ongoing study at the University of Utah and the Huntsman Cancer Institute."
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