BERLIN and SEATTLE, April 18, 2007 (PRIME NEWSWIRE) -- Epigenomics AG (Frankfurt:ECX), a cancer molecular diagnostics company developing tests based on DNA methylation, yesterday presented the most recent data from its colorectal cancer screening test development program at the Annual Meeting 2007 of the American Association for Cancer Research (AACR) in Los Angeles, CA, U.S.A. The data presented showed that a modification of the assay procedure and rules for test result interpretation significantly improved the performance of Epigenomics' proprietary DNA-Methylation biomarker Septin 9 for the early detection of colorectal cancer in blood plasma.
"After having shown in 2005 that Septin 9 is an outstanding DNA methylation biomarker for colorectal cancer early detection, we consider this a breakthrough in performance improvement of this biomarker in blood plasma," commented Christian Piepenbrock, COO of Epigenomics. "This biomarker is methylated in about 90% of all colorectal tumors and understanding the key technical determinants that drive its performance in plasma measurements allows for systematic optimization of the assay procedure for routine use. These assay improvements will benefit not only our Septin 9 test but also the biomarkers in our other cancer screening programs."
The poster presentation by Cathy Lofton-Day, Ph. D., Vice President Molecular Biology of Epigenomics, focused on the benefits of modifications of the assay procedure and rules for test result interpretation on the performance of Septin 9 for the early detection of colorectal cancer in blood plasma. Using these modifications Septin 9 detected 70% (91 out of 130) of the colorectal cancers in the study and was falsely positive in only 10% (19 out of 183) of the cancer-free controls. When specificity was set at 97% (3% false positive rate in the non-cancerous controls) 63% of cancers were reliably detected. More importantly, the 70% cancer detection rate was also achieved in individuals found to have earlier stage disease (stage I-III, 75 out of 107).
Epigenomics is now focusing on further streamlining and simplification of the assay procedure to decrease test costs, improve ease-of-use and thus facilitate transfer into clinical routine use.
Further Information
The poster presented at the AACR Annual Meeting 2007 is available for download from Epigenomics' website at http://www.epigenomics.com/en/down_loads/Poster_Scientific_Publications/
About Colorectal Cancer Screening
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 is vitally important. The market for this type of test could reach about 300 million people worldwide. The gold standard screening test is colonoscopy, an invasive test, 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 develops such a blood-based test for the early detection of colorectal cancer by using cancer specific DNA methylation biomarkers for the detection of tumor DNA shed to the blood stream. After having validated Septin 9 as a biomarker with high prevalence in colorectal cancer in several large clinical studies in blood plasma by the end of 2005, much of 2006 was dedicated to finding biomarkers complementary to Septin 9 and, most importantly, further improving the assay procedure for DNA methylation biomarker testing in blood plasma and other body fluids. Epigenomics is currently optimizing the assay procedure in order to be able to transfer the Septin 9 biomarker assay into a US reference lab by the end of the year. A testing service for this biomarker could then start 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 US..
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.