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25.10.2011 | 111025_EU_Launch_EN

Presentation of the powerful second generation blood test for colorectal cancer screening during UEGW in Stockholm

Berlin, Germany, and Stockholm, Sweden

Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnostics company, today announced the upcoming launch of Epi proColon® 2.0 CE in Europe during the United European Gastroenterology Week (UEGW) in Stockholm, Sweden. Epi proColon® 2.0 CE is the Company’s second generation blood-based test for the early detection of colorectal cancer. The rollout of the new test is expected to start in the near future in Europe and other selected regions through Epigenomics and its network of distributors.

The announcement of the launch follows a thorough clinical validation in which the convenient blood test, optimized for maximum specificity for colorectal cancer, demonstrated an accuracy of detecting colorectal cancer that is unmatched by any other non-invasive method of colorectal cancer detection. In particular, the positive predictive value (PPV) of the test – a commonly used measure for the likelihood of actually having cancer when a test is positive – was found to be 45% in a large study evaluating its performance when compared to the PPV of only 10% reported for the most widely used stool tests for colorectal cancer (CRC) screening. To specifically meet market requirements in many European countries, the new product minimizes the number of false positive results while maintaining excellent sensitivity in CRC detection. Thus, Epi proColon® 2.0 CE detects more than 80% of all colorectal cancers at 99% specificity. With this high level of performance, the new test provides a reliable and convenient alternative to conventional methods of colorectal cancer screening such as stool tests.

Geert Nygaard, Chief Executive Officer of Epigenomics commented: “The combination of both high sensitivity and an almost perfect specificity in a single convenient and patient-friendly blood test is what sets Epi proColon® 2.0 CE apart from currently available in vitro diagnostic tests for colorectal cancer early detection. This test provides a compelling alternative for non-invasive colorectal cancer screening and has an unmatched potential to find acceptance among patients, doctors, and payers.”

Epi proColon® 2.0 CE not only has a significantly enhanced performance over the first generation Epi proColon® test, but it also features a number of other improvements that should facilitate its use for the diagnostic routine, including fewer reagents and handling steps and a shorter time to results. The test is optimized for the commonly used Roche LightCycler® 480 and the Applied Biosystems® 7500 Fast real-time PCR systems.

The new Epi proColon® 2.0 CE test can also be optimized for high sensitivity to colorectal cancer. The Company previously announced data from clinical validation of the blood test using an algorithm optimized for high sensitivity, in which the test demonstrated a sensitivity of 95% and a specificity of 85%.

Epigenomics will hold a press briefing at the UEGW, today, Tuesday, October 25, 2011 at 10:35 am CET at booth A13:34 in Hall A, Stockholmsmässan, Mässvägen 1, Älvsjö, 125 80 Stockholm, Sweden.

The briefing will include the following presentations:

  • Dr. Gunter Weiss, Epigenomics’ Vice President Product Development will give an overview on the development and technical improvements of Epi proColon®2.0 CE.
  • Dr. med. Juergen Beck, Senior Vice President Medical Affairs will point out the clinical advantages of the new Epi proColon® 2.0 CE.
  • An open discussion afterwards allows enough time for the plenum to ask questions.

Interested parties not present at UEGW can follow the presentations and contribute to the discussion in an audio webcast. The dial-in details for the audio webcast will be available on Epigenomics’ website at http://www.epigenomics.com/en/news-investors.html.

Contact Epigenomics AG

Dr. Achim Plum
Sen. VP Business & Strategy
Epigenomics AG
Tel +49 (0) 30 24345 368
pr@epigenomics.com
www.epigenomics.com

About Epigenomics

Epigenomics 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.