NEWTON, Mass. and BERLIN, Germany, April 12, 2007 (PRIME NEWSWIRE) -- Clinical Data, Inc. (NASDAQ:CLDA) and Epigenomics AG (Other OTC:EPGNF) (FSE:ECX) today announced an agreement to offer Epigenomics' proprietary DNA methylation services through Clinical Data's service division, Cogenics. Under this agreement, Cogenics will promote to its customers Epigenomics' comprehensive portfolio of DNA methylation services including genome-wide DNA methylation analysis, bisulfite sequencing, and real-time PCR technologies, which are performed in Epigenomics' laboratories in Germany. Additionally, the companies plan to offer regulated (GLP) DNA methylation analyses in Cogenics' laboratories in the U.S. Under the agreement, Epigenomics will promote Cogenics' comprehensive pharmacogenomics and molecular biology services to its DNA methylation biomarker development partners and customers that Epigenomics serves through its Clinical Solutions group.
Robert Bondaryk, Ph.D., Senior Vice President and General Manager of Cogenics, said, "We are very pleased to enter into this partnership agreement with Epigenomics and look forward to working closely with the company. We are excited to offer Cogenics customers Epigenomics' expertise and technology in DNA methylation services. This partnership brings unique value to our customers by expanding our current biomarker offering to now allow them to use DNA methylation as a marker of disease diagnosis, prognosis and drug response prediction."
Christina Dahlstroem, Ph.D., Senior Vice President of Epigenomics' Clinical Solutions group, said, "This reference laboratory partnership with Cogenics enables us to serve Cogenics' broad client base with our DNA methylation services and biomarker development expertise. We are excited about the prospect of eventually offering DNA methylation analysis in a regulated environment through Cogenics. This will be particularly important once our pharma partners want to use the biomarkers in clinical trials. In addition, we are enthusiastic about being able to offer our customers an even broader range of biomarker services, in addition to DNA methylation, through this partnership with Cogenics."
About DNA Methylation
DNA methylation is a tightly controlled biological process that fundamentally affects gene expression and genome stability. Cytosine, one of the four bases in DNA, can be modified by the covalent addition of a methyl group. DNA methylation in gene regulatory regions (i.e. gene promoters) in most cases causes the shut-down of gene activity. As different cells shut off different genes, every cell type has its unique DNA methylation "fingerprint" that changes in various normal biological processes and many common diseases, in particular cancer. DNA methylation thus provides a rich source for highly specific biomarkers for organ-specific disease diagnosis, classification and also the prediction to therapeutic intervention.
DNA methylation biomarkers have multiple advantages. Highly sensitive detection methods allow the detection of tumor derived DNA based cancer-specific DNA methylation patterns in body fluids such as blood or urine. Further, DNA methylation can easily be quantified as the unmethylated DNA of the same gene in the sample can serve as an internal reference. As DNA methylation is stable in routine clinical sample processing, it can be analyzed in tissue samples fixed and paraffin embedded for histological analysis by the pathologists. Epigenomics has developed a broad technology portfolio and the know-how to identify and validate DNA methylation biomarkers and use them for the development of molecular diagnostic tests.
About Cogenics
Cogenics offers more than 17 years of experience as a trusted provider of the broadest range of pharmacogenomics and molecular biology services available globally. Cogenics provides integrated services for nucleic acid extraction, genotyping, sequencing, QPCR, and gene expression, as well as serving as a biorepository, for both research and regulated environments: GLP, cGMP and CLIA. Cogenics combines operations from the acquisitions of Genaissance Pharmaceuticals, Lark Technologies (U.S. & UK), Icoria, and Genome Express (France). Its customers include some of the world's most respected pharmaceutical and biotechnology companies, agencies of the U.S. National Institutes of Health, leading government and academic researchers in the international life science community, and major agricultural companies and agencies.
About Clinical Data, Inc.
Clinical Data, Inc. is a global biotechnology company unlocking the potential of molecular discovery, from targeted science to better healthcare. Its Cogenics division provides molecular biology and pharmacogenomics services to pharmaceutical and biotech companies and academics institutions in both research and regulated environments. Its PGxHealth division focuses on genetic test and biomarker development to help predict drug safety and efficacy, thereby reducing health care costs and improving clinical outcomes. Its Vital Diagnostics division offers in vitro diagnostics solutions for the clinical laboratory. Through these divisions, Clinical Data is leveraging advances in molecular discovery to provide tangible benefits for patients, doctors, scientists, and health plans worldwide.
Internet Website: www.clda.com
About Epigenomics AG
Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics' tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics' defined business strategy covers two complementary core business areas: In cooperation with industry partners, the company develops diagnostic screening tests for the early detection of cancer, mass-market products with huge potentials. Based on easily obtainable body fluid samples (e.g. blood and urine), these tests are aimed at finding cancer at an early stage before symptoms occur. Epigenomics' product pipeline contains an extensively validated biomarker panel 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 body fluids. Epigenomics aims at giving patients and doctors early access to these biomarkers through reference laboratory testing services. For development and global commercialization as in vitro diagnostic test kits, Epigenomics pursues a non-exclusive partnering strategy with diagnostics industry players.
As a second core business area, Epigenomics develops specialty diagnostics for individuals at high risk for cancer and cancer patients. These tests include surveillance applications of our colorectal cancer biomarkers and a tissue-based prognostic cancer molecular classification test for prostate cancer patients. The biomarkers for cancer specialty diagnostic applications will be made available through testing services in centralized reference laboratories.
Pharma, diagnostics and biotech partners can access Epigenomics' portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 200 patent families through Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, Wash., USA. For more information, please visit Epigenomics' website at www.epigenomics.com.
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This press release contains certain forward-looking information about Clinical Data that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to statements regarding: our ability to successfully integrate the operations, business, technology and intellectual property obtained in our acquisitions; our ability to obtain regulatory approval for, and successfully introduce our new products and services; our ability to expand our long-term business opportunities; our ability to maintain normal terms with our customers and partners; financial projections and estimates and their underlying assumptions; and statements regarding future performance. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to: whether our services will gain wide acceptance in the market; our ability to achieve the expected synergies and operating efficiencies from all of our partnerships; the strength of our intellectual property rights; competition from laboratory services companies; general economic downturns; and other risks contained in our various SEC reports and filings, including but not limited to our Quarterly Report on Form 10-Q for the quarter ended December 31, 2006, and our subsequent Current Reports on Form 8-K filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.
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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.