Epigenomics AG

EANS-News: Epigenomics AG sponsored Felix Burda Award 2010

Company for the first time supported prestigious award for achievement in colorectal cancer screening Epigenomics' Septin9 blood test for colorectal cancer early detection available in Germany since October 2009 Research study aimed at enhancing blood test to detect precursor lesions nominated for the award

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Company Information/Molecular diagnostics

Subtitle: Company for the first time supported prestigious award for achievement in colorectal cancer screening

Epigenomics' Septin9 blood test for colorectal cancer early detection available in Germany since October 2009

Research study aimed at enhancing blood test to detect precursor lesions nominated for the award

Berlin, Germany, and Seattle, WA, USA, April 19, 2010 (euro adhoc) - Epigenomics AG a Berlin-based molecular diagnostics company that is dedicated to the development and introduction of innovative methods for the early detection and diagnosis of cancer, this year for the first time supported the Felix Burda Award which was awarded on April 18, 2010 during a gala at the Hotel Adlon in Berlin. Since 2003 the Felix Burda Foundation with this award honours the most successful, innovative and outstanding projects and achievements in colorectal cancer screening.

"Just like the Felix Burda Foundation we are convinced that an improved and effectively implemented screening is the key to reducing mortality from colorectal cancer", stated Dr. Achim Plum, Senior Vice President Corporate Development at Epigenomics AG. "We have the highest regard for the foundation's achievements since its establishment and feel honoured that with our support of the Award but also through our research and products for colorectal cancer early detection we can make a contribution to alleviating people's fears of this still far too often fatal disease."

In October 2009 Epigenomics AG introduced the world's first regulatory cleared test for colorectal cancer early detection in a simple blood draw in Europe. The so called Septin9 test sensitively detects tumor DNA in blood, which is a reliable indicator for the presence of a colorectal carcinoma. The test addresses individuals who should get screened for colorectal cancer but shy away from colonoscopy, the gold standard in colorectal cancer prevention, as a first-line approach to screening and who do not want to perform stool-based tests. The rejection of current methods leads to more than 50% of the eligible population not participating in screening in Germany. In particular for these people, the Septin9 test may provide a convenient alternative to get screened.

Contrary to currently available stool tests, for which patients are responsible themselves for the correct sampling, all the patient has to do for the Septin9 test is to agree to a blood draw at the family physician's office. No restrictions in diet or medications have to be followed before the test is performed. Thus, the patient can spontaneously decide to do the test at the family doctor's office. If tested positive for Septin9 the patient will be recommended to undergo a colonoscopy as a follow-up for definitive diagnosis. First experience with the Septin9 test in clinical routine show, that those patients who do test positive actually follow this recommendation.

In early 2010 the applicability of this new approach to population wide colorectal cancer screening has been demonstrated in a large prospective clinical study with approximately 8,000 study participants with average disease risk aged 50 years and older in Germany and the U.S.A. This PRESEPT study is one of the largest privately sponsored studies in colorectal cancer screening ever conducted.

"The Septin9 test was developed for the blood-based early detection of invasive colorectal carcinoma", Dr. Plum explained. "We have demonstrated the utility of the test for this application in the PRESEPT Study and in numerous previous case control studies. Our research now aims at further improving the blood test to even better find the particularly hard to detect early stage cancers and ideally also benign precursor lesions. We are excited that a clinical study found the attention of the jury, which was the starting point for a joint research project by Prof. Matthias Ebert of the Klinikum rechts der Isar in Munich, the Association of Statutory Health Insurance Physicians in Bavaria (KVB), and Epigenomics that is aimed at addressing these questions."

The Felix Burda Award is awarded in five categories: Medical Prevention, Public Prevention, Journalism for Prevention, Prevention at Work and Stars for Prevention.

Among the nominated projects in the category Medical Prevention was a study by Prof. Matthias Ebert and Marc Tänzer of the II. Medical Clinic, Klinikum rechts der Isar titled "Epigenetic Screening for Colorectal Adenomas - Results of a Study for the Validation of two Methylation Markers". This study together with Epigenomics' previous research is the starting point for the EpiTEK project, which started in July 2009 and will be sponsored for several years by the German Federal Ministry of Education and Research. Within EpiTEK, scientists of Prof. Ebert's group, the Association of Statutory Health Insurance Physicians in Bavaria (KVB) and scientists from Epigenomics AG work together in an innovative research alliance of academic science, healthcare providers and industry to further develop the Septin9 blood test with a focus on the detection of benign precursor lesions of the colorectal carcinoma, so called adenomas. In their statement on the nomination the jury of the Felix Burda Award pointed to the seminal character of this research approach with regard to the significant increase of participation in colorectal cancer screening and further highlighted the project's landmark character.

"From a scientific and clinical point of view this project reflects a novel approach to colorectal cancer prevention as it focuses for the first time on the non invasive screening for precursor lesions of the cancer", stated Prof. Ebert. "The nomination for the Felix Burda Award 2010 is a special honor for our previous, jointly performed studies. It is also a mandate to continue pursuing this concept within the EpiTEK study."

The Septin9 test

The Septin9 test was developed by Epigenomics as a blood test for the early detection of colorectal cancer. The test relies on the detection of methylated DNA of the Septin9 gene (mSEPT9) in blood plasma. It is the first of its kind worldwide. Under the brand name Epi proColon Epigenomics markets a CE-marked, in-vitro-diagnostic real time polymerase chain reaction (real-time PCR) test kit for the qualitative detection of mSEPT9 in bisulfite converted DNA isolated from human plasma samples. Presence of mSEPT9 is associated with, and may aid in, the detection of invasive colorectal adenocarcinoma. For further information and availability of the Septin9 test please go to: www.septin9test.de.

The EpiTEK project

Funded by the German Federal Ministry of Education and Research, EpiTEK is a clinical research project for the early detection of colorectal cancer, realized in an alliance of Scientists from the 2nd Medical Clinic of the University Hospital rechts der Isar at the Munich Technical University, the Association of Statutory Health Insurance Physicians in Bavaria (KVB) and Epigenomics AG, a molecular diagnostics company based in Berlin, Germany, and Seattle, WA, U.S.A. The project aims at the further developing Epigenomics' already available blood test for the detection of invasive colorectal cancer to detect already pre-malignant precursor lesions of the disease, so called adenomas and polyps. Compared to the currently recommended colonoscopy for the detection of polyps and tumors of the colon such an approach would be more convenient for individuals undergoing colorectal cancer screening. A non-invasive "polyp test" could thus complement currently available conventional prevention strategies including colonoscopy and thereby might significantly contribute to reducing mortality from colorectal cancer. For further information on the EpiTEK study please go to: www.myepitek.de.

About Epigenomics

Epigenomics 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 aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.

Epigenomics' product portfolio contains the CE-marked IVD test Epi proColon, the world's first regulatory cleared molecular diagnostic test for the detection of colorectal cancer in blood that is based on the biomarker Septin9, and further proprietary DNA methylation biomarkers and IVD products at various stages of development for colorectal, lung and prostate cancer. 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, U.S.A. For more information, please visit Epigenomics' website at www.epigenomics.com.

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

end of announcement                               euro adhoc

Further inquiry note:

Epigenomics AG
Dr. Achim Plum
Sen. VP Corporate Development
Tel: +49 30 24345 368

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