Epigenomics Optimizes Workflow for Testing its Proprietary Biomarkers for the Early Detection of Cancer in Blood Plasma

Epigenomics AG Gives Detailed Account of Research Into Optimized Assay Procedure for Early Cancer Detection at CHI's G.O.T. Summit


BERLIN and SEATTLE, April 13, 2007 (PRIME NEWSWIRE) -- Epigenomics AG (Frankfurt:ECX), a cancer molecular diagnostics company developing tests based on DNA methylation, yesterday presented research geared at developing a generic workflow for testing its proprietary DNA methylation biomarkers for the early detection of various types of cancer in blood plasma at the Cambridge Healthtech Institute's G.O.T. Summit in Boston, MA, U.S.A.

Theo deVos, Ph.D., Epigenomics' Vice President Development Diagnostics, presented data on workflow optimization resulting from the largest DNA methylation biomarker studies ever done in blood plasma including several hundred colorectal cancer patients and control individuals over the past years. The presentation titled "Optimizing the detection of DNA-based biomarkers in blood plasma" systematically addressed workflow requirements for the reliable and sensitive detection of tumor-derived DNA in the blood stream with DNA methylation biomarkers using Epigenomics' proprietary colorectal cancer biomarker Septin 9 as an example. Dr. deVos presented data demonstrating that by using Epigenomics' proprietary MethylLight and HM technologies to measure methylated Septin 9, the DNA equivalent of only about two tumor cells can be detected in a sample. Further data showed that Epigenomics had successfully standardized the sampling procedure for blood plasma and had optimized the recovery of free floating DNA from the plasma samples and its preparation for methylation analysis by proprietary bisulfite treatment protocols.

Epigenomics used this research grade assay procedure in late 2006 to demonstrate that the presence of methylated Septin 9 DNA in blood plasma reliably indicated the presence of tumors of all stages in colorectal cancer patients with a high specifity and sensitivity.

"We believe that the insight we gained into the critical workflow determinants for the early detection of colorectal cancer allows us to develop a generic assay procedure for DNA methylation biomarkers in body fluids that also is applicable to other cancer indications," commented Christian Piepenbrock, COO of Epigenomics. "This notion is also supported by the extraordinary results we obtained last year in our prostate cancer screening program."

Based on the findings gathered in these studies and outlined by Dr. deVos, Epigenomics is now optimizing generic assay procedure with respect to costs, time, and simplicity for clinical routine use.

Further Information

Epigenomics' presentation at the G.O.T. Summit yesterday was a contribution to the Cambridge Healthtech Institute's 7th Annual Conference on Genomic Sample Preparation: Optimizing Samples for Diagnostics and Drug Discovery. The full presentation can be downloaded from Epigenomics' website at http://www.epigenomics.com/en/down_loads/Poster_Scientific_Publications/

About Epigenomics AG

Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics' tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics' defined business strategy covers two complementary core business areas:

In cooperation with industry partners, the company develops diagnostic screening tests for the early detection of cancer, mass-market products with huge potentials. Based on easily obtainable body fluid samples (e.g. blood and urine), these tests are aimed at finding cancer at an early stage before symptoms occur. Epigenomics' product pipeline contains an extensively validated biomarker panel for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate and lung cancer detection in body fluids. Epigenomics aims at giving patients and doctors early access to these biomarkers through reference laboratory testing services. For development and global commercialization as in vitro diagnostic test kits, Epigenomics pursues a non-exclusive partnering strategy with diagnostics industry players.

As a second core business area, Epigenomics develops specialty diagnostics for individuals at high risk for cancer and cancer patients. These tests include surveillance applications of our colorectal cancer biomarkers and a tissue-based prognostic cancer molecular classification test for prostate cancer patients. Our tissue-based prostate cancer application is developed in strategic partnerships with Qiagen (pre-analytics) and Affymetrix (diagnostic device platform). The biomarkers for cancer specialty diagnostic applications will be made available through testing services in centralized reference laboratories. Epigenomics retains the flexibility to decide on further commercialization as in vitro diagnostic test kits in Europe and eventually the U.S. in the midterm.

Pharma, diagnostics and biotech partners can access Epigenomics' portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 200 patent families through Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, USA. For more information, please visit Epigenomics' website at www.epigenomics.com.

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.