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EANS-News: Epigenomics AG reports progress in clinical development of its colorectal cancer blood test during Digestive Disease Week
mSEPT9 biomarker facilitates innovative blood test for colorectal cancer mSEPT9 data published in Clinical Chemistry PRESEPT Study for colorectal cancer screening with mSEPT9 well on track
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new product/research/Molecular diagnostics
Press release, Berlin, Germany, and Seattle, WA, USA, June 2, 2009 (euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a molecular diagnostics company focusing on the development and commercialization of products for cancer detection based on DNA methylation, today reports on the status and progress in the clinical development of its blood test for colorectal cancer in a poster presentation during this year's Digestive Disease Week (DDW) in Chicago. The test, which is able to detect colorectal cancer in a simple blood draw, is based on Epigenomics' patented mSEPT9 biomarker. The Digestive Disease Week is the largest and most prestigious conference for gastroenterologists worldwide.
Dr. Catherine Lofton-Day, Vice President Molecular Biology and project manager of the PRESEPT Study at Epigenomics, will present an overview on Epigenomics' discovery and clinical validation work for the mSEPT9 biomarker. In particular she will focus on the results of two case-control studies with several hundred patients finished in 2008 to demonstrate the performance of the mSEPT9 biomarker in detecting colorectal cancer in blood samples. The study results were recently published in a peer-reviewed publication in Clinical Chemistry titled "Circulating Methylated Septin 9 DNA in Plasma is a Biomarker for Colorectal Cancer".
"The two case control studies now published are the latest in a series of seven published studies with over 3,000 cancer patients and controls in which we demonstrated the underlying principle of the test that our mSEPT9 assay reliably detects DNA derived from colorectal tumors in blood samples, thereby indicating the presence of colorectal cancer of all stages", explained Dr. Lofton-Day.
Furthermore Dr. Lofton-Day will focus on the progress of the PRESEPT Study that is sponsored by Epigenomics. PRESEPT is a multi-center, multinational clinical study to prospectively evaluate the clinical utility of the mSEPT9 testing for population-wide colorectal cancer screening. The study includes individuals at average to increased risk for colorectal cancer who have been scheduled for a screening colonoscopy in the U.S. The study population of about 7,500 individuals is expected to harbor about 50 cases with undetected colorectal cancer. The results of the mSEPT9 blood testing, which will be performed in independent laboratories, will be compared to the results of colonoscopy - the gold standard in colorectal cancer diagnosis - to demonstrate the performance of this innovative test in colorectal cancer screening. The performance characteristics determined in the PRESEPT Study will also provide input for a health economic evaluation of mSEPT9 blood testing for population-wide colorectal cancer screening. It is one of the first studies ever to evaluate the performance of a non-invasive test using a standard blood draw to indicate the presence of colorectal cancer in a cohort representing the colorectal cancer screening population.
"To this date we have made great progress in our PRESEPT Study and we are confident the original schedule will be kept with first results presented by the end of this year", explained Dr. Lofton-Day. According to Dr. Lofton-Day approximately 4,400 individuals have been enrolled into the study and more than half of the 50 expected cases with previously undetected colorectal cancers have been identified.
It is anticipated that a positive outcome of the PRESEPT Study would promote rapid acceptance among primary care physicians and gastroenterologists of this novel diagnostic method as an aid in detecting early stage colorectal cancer. Epigenomics and its partners intend to launch both an in vitro diagnostic mSEPT9-based blood test in Europe, and laboratory developed test (LDT) in the U.S. still in 2009.
2009 Digestive Disease Week Presentation Details
The poster titled "Circulating Methylated Septin 9 DNA in Plasma is a Biomarker for colorectal cancer" by Theo de Vos, Reimo Tetzner, Fabian Model, Gunter Weiss, Matthias Schuster, Juergen Distler, Robert Grützmann, Christian Pilarsky, Jens K. Habermann, Phillip Fleshner, Benton M. Oubre, Robert W. Day, Andrew Sledziewski, Michael Wandell, and Catherine Lofton-Day will be presented at the Digestive Disease Week 2009 in Chicago, on June 2, 2009, 8 am - 5 pm at McCormick Place, South Hall, by Dr. Catherine Lofton-Day, Vice President Molecular Biology and Project Manager PRESEPT at Epigenomics.
Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics' tests in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.
Epigenomics' product pipeline contains a validated biomarker 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 urine, blood and bronchial lavage specimens. Epigenomics' biomarker mSEPT9 for the early detection of colorectal cancer in a simple blood sample has demonstrated continuously highest performance in multiple clinical studies with in total more than 3,000 individuals tested. A large prospective clinical study - PRESEPT - for evaluation of mSEPT9 in a screening population is currently under way (www.presept.net).
For development and global commercialization of in vitro diagnostic test products, Epigenomics pursues a non-exclusive partnering strategy. Strategic diagnostics industry partners include Abbott Molecular, Philips, Sysmex Corporation and Quest Diagnostics Incorporated for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products.
Partners in the health care industry and the biomedical research community can access Epigenomics' portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 150 patent families through research products, Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, U.S.A. For more information, please visit Epigenomics' website at www.epigenomics.com.
Epigenomics legal disclaimers. 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.
The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale in the United States. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S. have not been established.
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ots Originaltext: Epigenomics AG
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