BERLIN and SEATTLE, May 21, 2007 (PRIME NEWSWIRE) -- Epigenomics AG (Frankfurt:ECX) and Prof. Dr. Matthias Ebert, Professor of Clinical and Molecular Gastroenterology at the University Hospital of the Technical University of Munich, Germany, yesterday presented new data supportive of Epigenomics Colorectal Cancer Screening Test Development Program at the Digestive Disease Week 2007 in Washington D.C., U.S.A. The results were a product of collaborative clinical studies with Epigenomics, a molecular diagnostics company developing cancer tests based on DNA methylation.
Prof. Ebert pointed out that colorectal cancer mortality could be reduced by detecting precancerous lesions and early stage disease before symptoms occur through convenient organ-specific blood screening tests such as those under development at Epigenomics. Prof. Ebert reviewed a data set demonstrating that the presence of methylated Septin 9 DNA in blood plasma can detect the presence of colorectal cancers of all stages. Additionally, when Septin 9 is combined in a panel with a second DNA methylation biomarker, ALX4, large polyps, pre-cancerous lesions that have a high likelihood of progressing to malignant tumors can also be detected in blood.
For the first time, Prof. Ebert presented original data showing that methylation of the Septin 9 gene is specific to colorectal cancer as it is rarely found in the blood of patients with other cancers or other gastrointestinal diseases.
"Biomarkers that are specific for cancer and the organ in which the cancer occurs are fundamental to effective screening tests," Prof. Ebert commented. "Such biomarkers allow focusing on the correct organ for definitive diagnosis and help to provide individualized diagnosis for the affected patients more rapidly."
The Digestive Disease Week is considered the largest and most prestigious meeting in the world for the gastrointestinal professional.
Further Information
The slides of Prof. Ebert's presentation at the Digestive Disease Week 2007 are available for download from Epigenomics' website at http://www.epigenomics.com/en/down_loads/Poster_Scientific_Publications/
About Colorectal Cancer Screening and Epigenomics' Biomarkers
Colorectal cancer is the second leading cause of cancer related death. With a cure rate over 90% if diagnosed in early stages, early detection through screening tests is vitally important. The market for this type of test could reach about 300 million people worldwide. The gold standard diagnostic test is colonoscopy, an invasive procedure, whereby the physician visually inspects the inside of the colon. This procedure, which has excellent specificity and sensitivity characteristics, not only identifies cancer but also pre-cancerous lesions known as adenomas. Due to the nature of this procedure and its high cost, it is currently not widely used for first line screening in short intervals. A non-invasive first-line screening test therefore should be used to screen larger numbers to identify individuals at risk of having the disease so that they then undergo colonoscopy. Currently, most non-invasive screening is carried out with the fecal occult blood testing (FOBT) procedure using stool samples. However, due to the inconvenient nature of the test, the compliance rate is comparatively low (approximately 16% in the US). The introduction of a more convenient, patient-friendly, competitively performing screening test could potentially increase the number of individuals tested in shorter intervals. If positive, the patients would be followed up by colonoscopy. This could greatly increase the chances of the disease being caught early with the goal of reducing mortality from colorectal cancer.
Epigenomics' technology is able to detect only a few copies of tumor DNA based on tumor-specific DNA methylation patterns in blood plasma samples or other body fluids. Based on this principle Epigenomics develops convenient tests for the early detection of colorectal and other cancers. The Septin 9 gene encodes a protein involved in cell division and is thought to play a role in the onset of cancer. Epigenomics demonstrated in multiple clinical studies with about 3,000 blood plasma samples of colorectal cancer patients, healthy controls, and patients with non-cancerous colon diseases that methylated DNA of Septin 9 shed by tumors into the blood stream can serve as a biomarker for the sensitive and specific detection of colorectal cancer of all stages and in all locations. The ALX4 gene encodes for a putative transcription factor, suggesting a role in gene regulation. The presence of methylated DNA of both genes, Septin 9 and ALX4, in the bloodstream indicates the presence of larger colon polyps that have a high likelihood of progressing to colon cancer.
Epigenomics is currently optimizing the assay procedure in order to transfer the Septin 9 biomarker assay into a centralized US reference laboratory by the end of the year. A testing service for this biomarker could begin in 2008.
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.
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.