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EANS-News: Epigenomics' Licensee ARUP Reports Excellent Validation Results for Septin9 Colorectal Cancer Blood Test
Presentation at ASCO - NCI - EORTC Molecular Markers Meeting
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Company Information/Molecular diagnostics
Subtitle: Presentation at ASCO - NCI - EORTC Molecular Markers Meeting
Berlin and Seattle - October 20, 2010 (euro adhoc) - Epigenomics AG's (Frankfurt Prime Standard: ECX) licensee, ARUP Laboratories, yesterday presented results from a positive clinical validation study for its Septin9 laboratory-developed test for the blood-based detection of colorectal cancer.
In a poster presentation at the 2010 ASCO-NCI-EORTC* Annual Meeting on Molecular Markers, in Hollywood, FL, USA, Karen A. Heichman, PhD, Vice President of Oncology Technology Development & Licensing at ARUP, reported that ARUP's Septin9 test found 90% of the cancer cases at a specificity of 89% in the validation study.
ARUP's colorectal cancer blood test is based on Epigenomics' proprietary Septin9 biomarker and DNA methylation technologies non-exclusively licensed to ARUP in August 2009. ARUP made the test available as a laboratory service in July 2010. The Septin9 test detects methylated cell-free DNA of the Septin9 gene shed by the tumor into the blood stream.
ARUP also reported supportive tissue data, which indicates that methylation of Septin9 is an early event in the development of colorectal cancer. The data demonstrated that the biomarker can be found in malignant and premalignant lesions independent of location in the colon, which is consistent with the equally good performance of the blood test for proximal and distal cancers.
"ARUP's study represents an additional independent validation of the Septin9 biomarker in plasma. It underscores the unique potential of our proprietary Septin9 biomarker as an aid in the detection of colorectal cancer when followed up with colonoscopy," commented Geert Nygaard, Chief Executive Officer of the Berlin and Seattle based cancer diagnostics company Epigenomics. "As a single biomarker test, it compares very favorably in terms of clinical performance and economics to competing molecular diagnostic approaches to stool and blood testing."
ARUP Laboratories' Septin9 blood test, which is now available to physicians and patients in the US, is not meant to replace colonoscopy but primarily targets patients who cannot or will not undergo the established screening methods.
The lack of compliance to conventional screening methods such as colonoscopy and stool tests is considered to be the biggest hurdle to effective colorectal cancer screening today. Screening experts believe that a convenient blood test that can be integrated into a regular check-up in the doctor's office may greatly enhance compliance among the more than 80 million US citizens aged 50 years and older for which current guidelines recommend regular colorectal cancer screening.
*ASCC - NCI - EORTC: American Society of Clinical Oncology- National Cancer Institute - European Organization for Research and Treatment of Cancer
For more information, please contact:
Contact ARUP Laboratories
Kristofer Beldin Tel (801) 583-2787, ext. 2451/(801) 946-2987 (cell) firstname.lastname@example.org
Cyndee Holden Tel (801) 583-2787, ext. 3318/(801) 386-6637 (cell) email@example.com
Contact Epigenomics AG
Notes to Editor
Epigenomics AG 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 for colorectal, lung, and prostate cancer aim at aiding in an earlier and more accurate diagnosis of these diseases thereby potentially increasing the patient's chances of survival.
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, USA. For more information, please visit Epigenomics' website at www.epigenomics.com
About ARUP Laboratories
Founded in 1984, ARUP Laboratories is a leading national reference laboratory and an enterprise of the University of Utah and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. ARUP serves clients across the United States, including many of the nation's top university teaching hospitals and children's hospitals, as well as multihospital groups, major commercial laboratories, group purchasing organizations, military and other government facilities, and major clinics. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Clinical and Experimental Pathology®. For more information, please visit the website: www.aruplab.com
About the Septin9 Biomarker and Colorectal Cancer Blood Tests
The Septin9 biomarker is at the core of the world's first molecular diagnostic blood tests for the detection of colorectal cancer commercialized by Epigenomics (Epi proColon) and its Partner Abbott Molecular (mS9) as IVD test kits in Europe and Asia/Pacific and its licensees Quest Diagnostics (ColoVantage?) and ARUP laboratories (Methylated Septin9 Test) as laboratory-developed tests in the US. The tests all detect cell-free methylated DNA of the Septin9 gene shed into the blood stream by colorectal.
In numerous studies, Epigenomics and its partners have demonstrated that the detection of the Septin9 biomarker in blood plasma correlates with the presence of colorectal cancer and thus can be used as an aid in the detection of this common cancer. These studies include the successfully completed PRESEPT Study, a prospective evaluation of the Septin9 biomarker in a cohort of almost 8,000 individuals representative of a typical screening population.
Today, Septin9 is likely the most thoroughly tested and best studied molecular diagnostic biomarker for colorectal cancer detection.
Lack of patient adherence to screening recommendations is the biggest hurdle to an effective screening for colorectal cancer. Experts believe that a blood test that is more convenient for the patients than stool tests and colonoscopy could help to get more people screened and thus be of medical and health economic benefit.
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 by Epigenomics in the United States of America. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time by Epigenomics in the USA have not been established.
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