Warnex to offer a laboratory-developed blood testing service based on Epigenomics' Septin9 Biomarker
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Licensing Agreements/Molecular diagnostics
Subtitle: Warnex to offer a laboratory-developed blood testing service based on Epigenomics' Septin9 Biomarker
Press release Berlin, Germany, and Laval, QC, Canada, May, 03, 2010 (euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a cancer molecular diagnosis company and Warnex Medical Laboratories, a division of Warnex Inc. (TSX: WNX), a Canadian life sciences company, today announced that they have signed a non-exclusive licensing agreement for Epigenomics' colorectal cancer biomarker Septin9. Under the terms of the agreement, Warnex has obtained the rights to establish a laboratory-developed test for Septin9 and offer colorectal cancer blood testing services in Canada. Warnex plans to launch the testing service in the next few months. As the first laboratory to offer Septin9 testing in Canada, Warnex, subject to certain conditions, enjoys a time-limited head-start period of exclusivity for the Canadian market. Epigenomics will be entitled to certain royalty payments. Further contractual details were not disclosed.
In numerous studies with over 3,300 blood samples, Epigenomics has demonstrated that methylated DNA of the Septin9 gene in blood plasma is a reliable indicator of colorectal cancer of all stages and all locations. This paved the way for a convenient blood test for colorectal cancer early detection that can easily be integrated into the patient's routine physical, is non-invasive and does not require any drug or dietary restrictions.
"Warnex is the ideal partner to make colorectal cancer blood testing based on our Septin9 biomarker available in Canada. This agreement is an important further step in the international rollout of Septin9 testing, which is already commercially available in the US and Europe", commented Geert Nygaard, Chief Executive Officer of Epigenomics.
Colorectal cancer is the second-leading cause of cancer death in Canada. In 2009, an estimated number of 22,000 Canadians were diagnosed with the disease and 9,100 died from it. As colorectal cancer is largely curable when detected in early, still localized stages, the Colorectal Cancer Association of Canada recommends that all Canadians age 50 and over undergo screening with a test detecting blood in stool (fecal occult blood test or fecal immunochemical test) at least once every two years. If a test is positive for blood, a colonoscopy should be performed to determine the cause of bleeding. Despite the clear benefits of colorectal cancer screening in reducing mortality from this disease, only 4% to 14% of eligible Canadians follow the screening recommendations. Innovative convenient screening methods could greatly increase compliance with current guidelines and thereby contribute to reducing mortality from colorectal cancer.1
"We are pleased to add this colorectal cancer test based on real-time PCR technology to our service offering as part of our continued commitment to offering the most advanced specialized diagnostic services to Canadian healthcare professionals," said Mark Busgang, President and CEO of Warnex. "This blood test, using Epigenomics' Septin9 biomarker, offers an easy and accurate method to help diagnose patients with colorectal cancer."
Warnex (www.warnex.ca) is a life sciences company devoted to protecting public health by providing laboratory services to the pharmaceutical and healthcare sectors. Warnex Analytical Services provides pharmaceutical and biotechnology companies with a variety of quality control services, including chemistry, chromatography, microbiology, method development and validation, and stability studies. Warnex Bioanalytical Services specializes in bioequivalence and bioavailability studies for clinical trials. Warnex Medical Laboratories provides specialized testing for the healthcare industry as well as pharmaceutical and central laboratory services. Warnex PRO-DNA Services offers DNA identification tests for paternity, maternity and other family relationships, as well as for immigration and forensic testing purposes. Warnex has three facilities located in Laval and Blainville, Quebec, and Thunder Bay, Ontario.
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.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS BY WARNEX Certain statements contained in this news release are forward-looking and are subject to numerous risks and uncertainties, known and unknown. For information identifying known risks and uncertainties, relating to financial resources, liquidity risk, key customers and business partners, credit risk, foreign currency risk, government regulations, laboratory facilities, volatility of share price, employees, suppliers, and other important factors that could cause actual results to differ materially from those anticipated in the forward-looking statements, please refer to the heading Risks and Uncertainties in Warnex's most recent Management's Discussion and Analysis, which can be found at www.sedar.com. Consequently, actual results may differ materially from the anticipated results expressed in these forward-looking statements.
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.
References: 1 http://www.britannica.com/bps/additionalcontent/18/3156 3639/Reasons-for-Declining-Colorectal-Cancer-Screening-by-Older-Canad ians-A-Pilot-Study
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