Epigenomics AG: Screening More People for Colorectal Cancer with Septin9 Blood Tests Could Provide Medical Benefit and Be Cost-Effective

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 (Ref. 1). 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 (Ref. 2).

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 (Ref. 3).

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.”

-Ends-

About Colorectal Cancer

For 2011 the American Cancer Society expects an estimated 140,000 new cases of colorectal cancer to be diagnosed in the United States and almost 50,000 U.S. citizens to die from the disease. The 5-year survival rate is over 90% if the disease is treated in early stages but diminishes to about 12% once the cancer has affected other organs. Today, the majority of cancers are still found in advanced stages due to insufficient patient compliance to screening recommendations that leaves 47% of the population unscreened. Increasing compliance to regular cancer screening in the population aged 50 years and older is considered key to decreasing mortality from this disease. (Ref. 4)

References

Ref. 1: Ladabaum, Uri; Allen, John I.; Wandell, Michael; Ramsey, Scott: Screening for Colorectal Cancer with a Blood Test: Projected Effectiveness and Cost-Effectiveness of a Novel Plasma Methylated Septin-9 DNA (mSEPT9) Assay. Oral presentation at Digestive Disease Week 2011, May 7-10 2011, Chicago, IL, U.S.A. (Abstract #220)

Ref. 2: Church et al.: Methylated SEPT9 Gene in Plasma as a Marker for Detection of Occult Colorectal Cancer in a Screening Population. Oral presentation at Digestive Disease Week 2010, May 1-5, 2010, New Orleans, LA, U.S.A. (Abstract #711d)

Ref. 3: Taber, Jennifer M.; Aspinwall, Lisa G.; Heichman, Karen; Kinney, Anita Y.: Blood-based colorectal cancer screening: Eliciting attitudes and determining predictors of interest in a multiethnic sample. Poster presentation at the 35th Annual Meeting of the American Society of Preventive Oncology, March 4-8, 2011, Las Vegas, NV, U.S.A.

Ref. 4: American Cancer Society. Colorectal Cancer Facts & Figures 2011-2013. Atlanta: American Cancer Society, 2011.

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon^®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.

Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.