Epigenomics AG: New Clinical Data for Septin9 Colorectal Cancer Blood Test Presented at UEGW

Epigenomics AG, the cancer diagnostics company, announced that new data obtained in a clinical study with the Company’s proprietary Septin9 biomarker for the blood-based detection of colorectal cancer, were presented yesterday at the 18^th United European Gastroenterology Week (UEGW) in Barcelona, Spain.

The new data were presented by Dr. Juergen Beck, MD, who recently joined Epigenomics as Senior Vice President Medical Affairs, and validate findings in the successfully completed prospective PRESEPT Study, also presented at the conference.

In the PRESEPT Study, Epigenomics’ proprietary Septin9 blood test detected 67% of the colorectal cancer cases at a specificity of 88% when compared to colonoscopy, the gold standard in colorectal cancer detection. PRESEPT is a prospective evaluation of the Septin9 biomarker in a study cohort representative of the screening population for colorectal cancer. Almost 8,000 individuals undergoing colonoscopy for routine colorectal cancer screening were enrolled at 32 clinical sites in the US and Germany over a period of about 18 months in this benchmark study. The study was sponsored by Epigenomics, the discoverer of the Septin9 biomarker. It is the largest privately sponsored study in colorectal cancer screening ever conducted.

In his poster presentation Dr. Beck further presented data obtained in a smaller case-control study following the large PRESEPT Screening Study to independently validate the diagnostics assay that had been used in the PRESEPT Study. Investigators in an independent third-party laboratory analyzed cancer cases and colonoscopy-negative controls following the PRESEPT testing protocol. Within this study, the data of which have not been presented before, a sensitivity of 86% and a specificity of 93% were observed.

”The prospective PRESEPT Study has established that a plasma-based marker can be used to detect colorectal cancer in asymptomatic individuals,” concluded Prof. Dr. Thomas Roesch, Medical Director of the Department of Interdisciplinary Endoscopy at the University Hospital Hamburg-Eppendorf and Study Director of PRESEPT in Germany. "Further investigations will look into acceptance and uptake to determine whether the Septin9 test will help to get more people screened for colorectal cancer as well as cost-benefit aspects.”

Prof. Roesch was chairing a round table of international colorectal cancer screening experts to review and discuss the results of the PRESEPT Study. The round table was jointly organized by Epigenomics and its commercialization partner Abbott Molecular and took place in Barcelona concurrent with the UEWG. Both companies offer CE-marked in vitro diagnostic (IVD) test for the detection of the Epigenomics’ proprietary Septin9 biomarker in blood plasma as an aid in the detection of colorectal cancer in Europe and Asia/Pacific. Epigenomics and Abbott Molecular are also working on making Septin9 assays available as FDA-cleared IVD test kits for the US market.

"The PRESEPT Study and the independent validation of the assay system used demonstrates the clinical utility of Septin9 testing as an aid in the detection of colorectal cancer when followed up with colonoscopy and underscores once again the unique potential of our proprietary Septin9 biomarker,” commented Geert Nygaard, Chief Executive Officer of Epigenomics. "As a single biomarker test, the Septin9 test compares very favorably in terms of clinical performance and simplicity of handling and interpretation to emerging competing molecular diagnostic approaches to stool and blood testing for colorectal cancer.”

Notes to Editors

About Epigenomics

Epigenomics AG is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests on the market and in development for colorectal, lung, and prostate cancer aim at aiding in an earlier and more accurate diagnosis of these diseases thereby potentially increasing the patient’s chances of survival.

For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Sysmex Corporation, Quest Diagnostics Incorporated, and ARUP Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products.

The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc., in Seattle, WA, USA. For more information, please visit Epigenomics’ website at www.epigenomics.com.

About the Septin9 Biomarker and Colorectal Cancer Blood Tests

The Septin9 biomarker is at the core of the world’s first molecular diagnostic blood tests for the detection of colorectal cancer commercialized by Epigenomics (Epi proColon) and its Partner Abbott Molecular (mS9) as IVD test kits in Europe and Asia/Pacific and its licensees Quest Diagnostics (ColoVantage™) and ARUP Laboratories (Methylated Septin9 Test) as laboratory-developed tests in the US. The tests all detect cell-free methylated DNA of the Septin9 gene shed into the blood stream by colorectal tumors.

In numerous studies, Epigenomics and its partners have demonstrated that the detection of the Septin9 biomarker in blood plasma correlates with the presence of colorectal cancer and thus can be used as an aid in the detection of this common cancer. These studies include the successfully completed PRESEPT Study, a prospective evaluation of the Septin9 biomarker in a cohort of almost 8,000 individuals representative of a typical screening population.

Today, Septin9 is likely the most thoroughly tested and best studied molecular diagnostic biomarker for colorectal cancer detection.

Lack of patient adherence to screening recommendations is the biggest hurdle to an effective screening for colorectal cancer. Experts believe that a blood test that is more convenient for the patients than stool tests and colonoscopy could help to get more people screened and thus be of medical and health economic benefit.

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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 of America. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the USA have not been established.