BERLIN and SEATTLE, Oct. 4, 2007 (PRIME NEWSWIRE) -- Epigenomics AG (Frankfurt:ECX) (ISIN: DE000A0BVT96) today announced that key patents covering Epigenomics' core technology HeavyMethyl(r) for the sensitive detection of methylated DNA have been granted by the patent authorities in a wide range of market regions including Europe (Patent EP 1 370 691) and the U.S. (Patent U.S. 7,229,759).
Epigenomics, a cancer molecular diagnostics company, uses this technology for detecting DNA methylation biomarkers for the early detection of cancer. These biomarkers, when measured in body fluids such as blood plasma or urine, form the basis for Epigenomics' reliable and patient-friendly cancer screening tests in development. The most advanced product is a blood test for the early detection of colorectal cancer based on Epigenomics' proprietary DNA methylation biomarker Septin 9.
In numerous clinical studies with blood samples from more than 3,000 individuals, Epigenomics could demonstrate that measuring methylated Septin 9 DNA with HeavyMethyl(r) technology can detect colorectal cancer at early stages before symptoms typically occur. Diagnosed early, colorectal cancer has a 5-year survival rate of more than 90%. A Septin 9 based regular screening blood test for the early detection of colorectal cancer may eventually target almost 300 million men and women aged 50 and older in Europe, the U.S., and Japan.
"We believe that our HeavyMethyl(r) technology addresses some of the major shortcomings of competing technologies for sensitive DNA methylation biomarker detection. It is at the core of our cancer screening products in development. With the granted patents to this technology we secure our leading position in DNA methylation," commented Dr. Kurt Berlin, Chief Scientific Officer of Epigenomics.
Together with further key patents in the areas of sample preparation and DNA methylation detection technologies already issued in Europe and the U.S., the granted HeavyMethyl(r) patents complete the patent protection of the entire workflows for Epigenomics' diagnostic tests on body fluids and tissue.
About DNA methylation
DNA methylation is a natural and tightly controlled biologicalprocess that serves the regulation of genes and the stability of the human genome. Cytosine, one of the four bases in DNA, can be modified by the covalent addition of a methyl group. DNA methylation in gene regulatory regions (i.e. gene promoters) helps control gene activity.Every cell type has its unique DNA methylation "fingerprint" that changes in various normal biological processes and in many diseases,in particular cancer. In our opinion, DNA methylation thus provides a rich source for highly specific biomarkers for organ-specific disease diagnosis, classification and prediction for therapeutic intervention.
Epigenomics believes that it has a leading position in DNA methylation. Its patent portfolio comprises more than 190 patent families of which more than 60 patents have been granted in one or more countries. The patents cover DNA methylation biomarkers in numerous cancer indications and other diseases as well as technologies for their discovery and testing in research and diagnostic applications.
About HeavyMethyl(r)
The HeavyMethyl(r) technology is ideally suited for detecting circulating, tumor-derived DNA in body fluids using tumor specific methylation "fingerprints" as biomarkers. Any methylation detection assay that would be applied to these samples must be capable of detecting small amounts of tumor DNA in the presence of background normal DNA. Heavy Methyl(r) uses real-time PCR (Polymerase Chain Reaction) with blockers and probes that ensure methylation-specific amplification and detection of DNA and avoids short comings of competing methods. It can reliably detect even few fragments of circulating tumor DNA in a patient blood sample that indicate the presence of a tumor already at very early stages. In combination with suitable DNA methylation biomarkers, Epigenomics applies this technology for the development of organ specific early cancer detection tests. As the underlying real-time PCR technology is the most commonly applied technology in molecular diagnostic, HeavyMethyl(r) is compatible with the vast majority of molecular diagnostic instruments in the market.
For further information please see Cottrell, SE. et al. A real-time PCR assay for DNA-methylation using methylation-specific blockers. Nucleic Acids Res. 2004 Jan 13;32(1):e10. (http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=373310&blobtype=pdf)
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 cancer at an early stage and help guide physicians to select an appropriate therapy. Epigenomics' defined business strategy covers two complementary core business areas:
The company develops diagnostic screening tests for the early detection of cancer. Based on body fluid samples (e.g. blood andurine), these tests are aimed at finding cancer at an early stage before symptoms occur. Epigenomics' product pipeline contains a 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 first strategic partner, Abbott Molecular licensed the worldwide non-exclusive rights to Epigenomics' proprietary Septin 9biomarker for colorectal cancer.
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.
Pharma, diagnostics and biotech partners can access Epigenomics' portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 190 patent families (granted patents and patent applications) 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.
Epigenomics' 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.