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Epigenomics AG Completes U.S. Clinical Validation Study for Colorectal Cancer Blood Test Epi proColon; Provides Update on U.S. Regulatory Plans

09.12.2011

Conference Call Scheduled for today, 9thDecember 2011 at 4 pm CET

Berlin, Germany, and Seattle, WA, U.S.A.

Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnostic company, today reports the completion of the clinical validation study for its second-generation colorectal cancer blood test Epi proColon in the U.S. The study was designed to measure the clinical performance of Epi proColon for the detection of colorectal cancer in comparison to colonoscopy and is part of the required data package to seek regulatory approval of the product in the U.S. In the reported study, Epi proColon detected 68% of the colorectal cancer cases (sensitivity) while correctly identifying 80% of the patients free of disease (specificity). While the results of the study represent the lower end of the expected performance data, the findings of the study confirm the results obtained in a previously conducted clinical study with the first generation of the company’s Epi proColon test in the same cohort of patients.

Study subjects tested were selected from a prospectively collected cohort of 7.940 individuals, defined as being at average risk for colorectal cancer by current screening guidelines and who underwent colonoscopy for colorectal cancer screening. The tested study cohort included 45 cancer cases. All plasma samples selected were blinded, randomized, and tested with Epi proColon at three independent laboratories in the U.S.

After consultation with the U.S. Food and Drug Administration (FDA), the company confirmed that the clinical data would be assessed as part of the regular Premarket Approval (PMA) review process. The Company will begin the regulatory process with the FDA by submitting the first module of its PMA this month. In addition to the clinical validation study data, Epigenomics will also perform a head-to-head comparative study for colorectal cancer detection through comparison with fecal immunochemical testing (FIT) for the purpose of demonstrating non-inferiority of Epi proColon to FIT. This study will also become an integral part of the PMA submission to the FDA and is anticipated to be completed in 2012.

Conference Call for Investors and Media

Epigenomics’ management will host a conference call to discuss the study results and to inform about the further process of the FDA submission at 4 pm CET (10 am EST) today, December 9, 2011.

The dial-in numbers for the conference call are:

Dial-in number (within Germany): 

+49 69 247 501 899

Dial-in number (within U.K.):

+44 203 147 4861 

Dial-in number (within the US):

+1 212 444 0297

 

Participants are kindly requested to dial in 10 minutes prior to the start of the call.

A recording of the conference call will be provided here on our website subsequently.

Contact Epigenomics AG

Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@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.