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EANS-News: Epigenomics AG: Laboratory Network synlab Now Offering Septin9 Testing
European diagnostic laboratory network synlab has started offering Septin9 blood testing through its 55 German sites synlab to measure Septin9 using Epi proColon kit on Applied Biosystems 7500 Fast Real-time PCR System; CE-marked kit now also validated for this instrument
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Company Information/New Products/Molecular Diagnostics
Subtitle: European diagnostic laboratory network synlab has started offering Septin9 blood testing through its 55 German sites
synlab to measure Septin9 using Epi proColon kit on Applied Biosystems 7500 Fast Real-time PCR System; CE-marked kit now also validated for this instrument
Berlin (euro adhoc) - Berlin, Germany, and Seattle, WA, USA, April 7, 2010 - Epigenomics AG (Frankfurt Prime Standard: ECX), a cancer molecular diagnostics company, today reports that synlab, one of the largest laboratory networks in Europe, has started offering the blood-based Septin9 test Epi proColon for colorectal cancer early detection through its 55 German sites. The test which is able to detect colorectal cancer in a simple blood draw is based on Epigenomics' patented Septin9 biomarker and is the first regulated molecular diagnostic blood test ever for colorectal cancer early detection offered in Europe. The test was introduced in October 2009 as a CE-marked in vitro diagnostic product in Europe. Additional offering of Septin9 testing through the synlab network significantly increases coverage in Germany as well as other countries making this innovative test even more broadly available to doctors and patients in Europe. Current colorectal cancer screening methods - including fecal occult blood tests (FOBT) and colonoscopy- are perceived to be inconvenient and laborious and are reluctantly and infrequently used by individuals aged 50 and older who should be screened at regular intervals. This lack of compliance to screening recommendations severely limits the effectiveness of national screening programs as the majority of cancer cases are detected in advanced stages when symptoms occur and the chances of survival are greatly diminished. The Septin9 colorectal cancer blood test is designed to be as convenient and patient friendly as possible: patients simply provide a blood sample in their doctors' office, e.g. as part of a regular health check-up. The sample is then shipped to a local, regional or national diagnostic laboratory where it is tested for the Septin9 biomarker. Dr. Wolfgang Schwabe, Head of Oncoscreen GmbH, Jena, the laboratory running the Septin9 test within the synlab network, stated: "We are excited by the potential of the Septin9 test to help doctors provide more convenient patient care. With the Septin9 test we have broadened our portfolio of oncology services which allows us to offer a more complete package of diagnostic services to doctors and their patients."
The test is based on the detection of methylated Septin9 DNA in blood. This epigenetic modification of the Septin9 gene can be detected in the vast majority of tumors in the colon and rectum. As tumors shed DNA into the bloodstream, the detection of circulating methylated Septin9 DNA with the sensitive Epi proColon real-time PCR assay is a reliable indicator of acute colorectal cancer.
Oncoscreen is the first laboratory to use a recently released version of the Epi proColon real-time PCR assay to detect the Septin9 biomarker in blood plasma. This reagent kit has now been validated for use with the Applied Biosystems 7500 Fast Real-Time PCR System of Life Technologies Inc. as well as Roche's LightCycler® 480 instrument on which the test was originally released in October 2009. Availability on two standard real-time PCR instrument platforms found in many clinical laboratories is expected to further facilitate making Septin9 testing broadly available in Europe.
"The Septin9 assay is very robust and can easily be optimized for different real-time PCR instruments, the standard technology platform in molecular diagnostics", commented Dr. Uwe Staub, Senior Vice President Product Development at Epigenomics. "This allows us as well as our partners to make Septin9 testing available as broadly as possible, an important prerequisite for a test that should eventually be used in population wide colorectal cancer screening."
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 Septin9, 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, 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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