05.05.2010 – 08:31
EANS-News: PRESEPT Study Results Sponsored by Epigenomics AG Presented at Digestive Disease Week
mSEPT9 biomarker successfully validated as the first biomarker in blood capable of detecting previously unsuspected colorectal cancers in prospective colorectal cancer screening study Final data to be submitted for publication in top-tier journal The CE marked Epi proColon assay, based on mSEPT9, provides attractive and convenient alternative for colorectal cancer screening
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Company Information/Studies/ Molecular diagnostics
Subtitle: mSEPT9 biomarker successfully validated as the first biomarker in blood capable of detecting previously unsuspected colorectal cancers in prospective colorectal cancer screening study
Final data to be submitted for publication in top-tier journal
The CE marked Epi proColon assay, based on mSEPT9, provides attractive and convenient alternative for colorectal cancer screening
Press release Berlin, Germany, and Seattle, WA, USA, May 05, 2010 (euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a cancer molecular diagnostics company, announced today that the PRESEPT Study results have been presented, in a Late-Breaking Abstracts Session during this year's Digestive Disease Week (DDW) in New Orleans. PRESEPT is a prospective multicenter multinational clinical research study started in 2008 to evaluate the performance characteristics and health economic benefit of colorectal cancer screening using Epigenomics' mSEPT9 blood biomarker in a screening population. Digestive Disease Week is the largest and most prestigious conference for gastroenterologists worldwide.
The results were presented by Timothy R. Church, Ph.D., University of Minnesota, Minneapolis, MN, U.S.A., Principal Investigator of the PRESEPT Study on behalf of the PRESEPT Clinical Study Steering Committee. The presentation summarized the results obtained from testing three replicates for the presence of mSEPT9, which exhibited a sensitivity of 66.7 % at a specificity of 88.4% in this cohort.
The final data of the PRESEPT Study will be submitted for publication to a top-tier journal for peer review in due course.
Dr. Catherine Lofton-Day, Vice President Molecular Biology and project manager of the PRESEPT Study at Epigenomics explained: "We are very pleased with the results of our PRESEPT Study. The results show that our mSEPT9 test meets the requirements for routine use in a true screening population and could provide an attractive alternative for patients not willing to accept current screening methods. Furthermore the test could have the potential to resolve the problem of poor patient compliance in CRC screening."
The PRESEPT Study is one of the largest commercially sponsored colorectal cancer screening clinical studies ever conducted. Between June 2008 and December 2009, in total 7,940 screening eligible average risk subjects were enrolled into the PRESEPT Study at 32 clinical sites in the U.S. and Germany. This study population contained 53 cases of previously unsuspected colorectal cancers that were identified by screening colonoscopies performed on all study participants. Over two-thirds of the 53 colorectal cancer cases identified in the cohort were early stage disease (Stages I and II) with a large proportion of the stage I colorectal cancer cases being very early stage disease (histopathologically described as pT1).
Tim Church on behalf of the CSSC concluded that this prospective, blinded study validates that a plasma-based marker can be used to detect preclinical colorectal cancer in asymptomatic individuals.
A simple blood test for colorectal cancer screening that is available for the large group of eligible patients, who are unwilling or unable to use other available methods, has the potential to address the lack of compliance with today's screening approaches. Based on the mSEPT9 marker performance data and the prevalence of colorectal cancer observed in the PRESEPT Study cohort, a primary care physician informing a patient of a mSEPT9 test result that is negative for colorectal cancer can do so with the confidence of it being correct 99.7% of the time (Negative Predictive Value).
Geert Nygaard, CEO of Epigenomics AG, further stated: "Having demonstrated the performance of our mSEPT9 biomarker in this prospective screening cohort is of tremendous value to our efforts of securing guideline inclusion and reimbursement in the major markets and thereby making a convenient blood-based colorectal cancer screening test available to the broader population."
2010 Digestive Week Presentation Details and other Activities
The presentation titled "Prospective clinical validation of an assay for methylated SEPT9 DNA in human plasma as a colorectal cancer screening tool in average risk men and women 50 years and older" presented by Timothy R. Church, PhD. has been held at the Digestive Disease Week 2010 (from May 1 - May 5, 2010), in New Orleans during a Late-Breaking Abstracts Session on Tuesday, May 4, 2010.
Furthermore Dr. Catherine Lofton-Day Vice President Molecular Biology and project manager of the PRESEPT Study at Epigenomics held a presentation titled "Looking into alternatives: blood-based tests for CRC screening" at the World Organization of Digestive Endoscopy (OMED) Meeting.
Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics' tests on the market and in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.
Epigenomics' product portfolio contains the CE-marked IVD test Epi proColon, the world's first regulatory cleared molecular diagnostic test for the detection of colorectal cancer in blood that is based on the biomarker mSEPT9, and further proprietary DNA methylation biomarkers and IVD products at various stages of development for colorectal, lung and prostate cancer. For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Sysmex Corporation, Quest Diagnostics Incorporated, and ARUP Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc., 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 outside of the European Union, 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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