Company Discovers Biomarkers for Prostate Cancer Aggressiveness

Epigenomics AG (Frankfurt, Prime Standard: ECX), a molecular diagnostics company developing tests based on DNA methylation, announced today the successful identification of a set of DNA methylation biomarkers that closely correlate with prostate cancer aggressiveness. Epigenomics has now successfully identified biomarkers for all five initial products in its diagnostic collaboration with Roche Diagnostics. Meeting this milestone triggered an undisclosed milestone payment to Epigenomics from Roche Diagnostics.

Using proprietary technologies, Epigenomics has discovered a panel of DNA methylation markers that closely correlate with the Gleason score in samples from prostatectomy (surgically removal of the prostate) patients. The Gleason score is currently the most widely used indicator of prognosis in prostate cancer. These candidate markers also correlate with the early prostate specific antigen (PSA) relapse after radical prostatectomy, even in patients with mid-range Gleason. In the future this could mean that those patients that have undergone a prostatectomy could be more effectively monitored for disease relapse.

The candidate biomarkers will now be incorporated into assays and validated against a large number of clinical tissue samples. Epigenomics’ prostate cancer molecular classification project is focused on developing a test that will be used following prostate biopsy to differentiate between aggressive and non-aggressive prostate cancer. Current techniques used to stratify prostate cancer patients and determine treatment options have only limited success because they are subjective and vary among individual pathology laboratories.

"The management of prostate cancer today is severely limited by the lack of reliable markers that predict the clinical course of the disease. The data from our studies show that these candidate markers could be used as informative prognostic markers and warrant further investigation. Our goal is to develop an in vitro test to differentiate between aggressive and non-aggressive prostate cancer that will be used to stratify patients for the appropriate level of treatment, reducing both under and over treatment" stated Gary Schweikhardt, Head of the SBU Diagnostics of Epigenomics. "We have now achieved all of he initial milestones set out in our collaboration with Roche Diagnostic and are excited about the continuous advances being made in this and all the other product development programs."

Epigenomics’ collaboration with Roche Diagnostics, a world leader in molecular diagnostics, involves the development of tests to diagnose prostate, colon and breast cancer; a test for molecular classification of prostate cancer; and a test to predict the probability of relapse in women treated with the standard breast cancer treatment, tamoxifen.

DNA Methylation

Methylation is a natural epigenetic process that occurs when a methyl group binds to one of DNA’s four bases, cytosine. The presence of methylation is responsible for controlling the activity of genes by turning them off, like a switch, when not needed. By measuring the differences in the methylation patterns between healthy and diseased tissue, a change in gene activity that could trigger diseases such as cancer is detected. Epigenomics has developed an industrial process that is able to read and interpret these methylation patterns.

About Epigenomics

Epigenomics is a molecular diagnostic company with a focus on the development of novel products for cancer. By detecting and interpreting DNA methylation patterns, Epigenomics’ tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics collaborates with Roche Diagnostics on the development of several diagnostic products in cancer. The company has its headquarters in Berlin, Germany, and a wholly owned subsidiary in Seattle, USA. For more information, please visit our website at www.epigenomics.com.

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Disclaimer

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.

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