SANTA CLARA, Calif., BERLIN and SEATTLE, June 27, 2006 (PRIMEZONE) -- Epigenomics AG (Frankfurt:ECX) (Prime Standard:ECX), a molecular diagnostics company developing tests based on DNA methylation, and Affymetrix Inc. (Nasdaq:AFFX) announced today that Affymetrix has granted Epigenomics non-exclusive access to Affymetrix microarray technology to develop and market microarray-based in-vitro diagnostic (IVD) tests for oncology and other indications.
The agreement complements Epigenomics' previously announced strategic alliance with Qiagen N.V. for sample preparation. Together, with the Affymetrix arrays and DNA analysis instrumentation, Epigenomics can now provide a complete platform for its pathology tests based on its proprietary DNA methylation methods. The first products based on this platform will be pathology tests in prostate and breast cancer. As the first example, Epigenomics is planning to transfer its Molecular Classification Test (MCT) for prostate cancer onto the Affymetrix platform to use it in the pivotal clinical trial for FDA approval of the assay, which is scheduled to start next year.
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"The agreement is another important step to turn Epigenomics into an integrated diagnostics company," said Alexander Olek, CEO of Epigenomics. "It has been our main focus over the last year to obtain gold-standard solutions for our own diagnostic products so that we can start marketing must-have diagnostic products meeting the highest industry standards. The 'Powered by Affymetrix' program allows us to join in to the Affymetrix open platform concept, which already provides Affymetrix diagnostic partners, among them several global players, with an excellent opportunity to benefit mutually from their respective strong placement power."
"Last year, we closed a strategic alliance with Qiagen to develop a cutting-edge solution portfolio for sample preparation," Olek added. "While the Qiagen alliance will provide us with robust, reliable, and easy-to-use kits for the preparation of clinical samples to enable the actual DNA methylation test, the agreement with Affymetrix now adds the industry standard for DNA analysis. As a result, our customers will get the world's leading technologies for rapid and reliable DNA methylation analysis."
"The microarray-based tools and applications in the Powered by Affymetrix(TM) program are accelerating the discovery and development of oncology companion and predictive diagnostics in this era of molecular medicine," said Noel Doheny, senior vice president, Molecular Diagnostics at Affymetrix. "We are pleased that another innovator in the diagnostic field like Epigenomics has adopted our proven technology platform for its in vitro diagnostic products."
Under the Powered by Affymetrix program, companies license technology from Affymetrix to develop innovative microarray products. This includes the GeneChip(R) System 3000Dx (GCS3000Dx), the first microarray instrumentation system for molecular diagnostic laboratories. The GCS3000Dx has been granted regulatory clearance by the U.S. Food and Drug Administration and is CE marked in the European Union for in-vitro diagnostic use. The custom-designed technology is being used in many applications, including clinical diagnostics, forensics, animal, industrial, and food testing.
About DNA methylation
Methylation is a natural epigenetic process that occurs when a methyl group binds to one of DNA's four bases, cytosine. The presence of methylation is responsible for controlling the activity of genes by turning them off, like a switch, when not needed. By measuring the differences in the methylation patterns between healthy and diseased tissue, a change in gene activity that could trigger diseases such as cancer is detected. Epigenomics has developed an industrial process that is able to read and interpret these methylation patterns.
About Epigenomics
Epigenomics is a molecular diagnostic company with a focus on the development of novel products for cancer. By detecting and interpreting DNA methylation patterns, Epigenomics' tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics collaborates with Roche Diagnostics on the development of several diagnostic products in cancer. The company has its headquarters in Berlin, Germany, and a wholly owned subsidiary in Seattle, USA. For more information, please visit our website at www.epigenomics.com.
About Affymetrix
Affymetrix scientists invented the world's first microarray in 1989 and began selling the first commercial microarray in 1994. Since then, Affymetrix GeneChip(R) technology has become the industry standard in molecular biology research. Affymetrix technology is used by the world's top pharmaceutical, diagnostic and biotechnology companies as well as leading academic, government and not-for-profit research institutes. More than 1,400 systems have been installed around the world and nearly 4,000 peer-reviewed papers have been published using the technology. Affymetrix' patented photolithographic manufacturing process provides the most information capacity available today on an array,enabling researchers to use a whole-genome approach to analyzing the relationship between genetics and health. Affymetrix is headquartered in Santa Clara, Calif., with subsidiaries in Europe and Asia, as well as manufacturing facilities in Sacramento, Calif., and Bedford, Mass. The company has about 1,000 employees worldwide. For more information about Affymetrix, please visit the company's Web site at www.Affymetrix.com.
All statements in this press release that are not historical are "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act as amended, including statements regarding Affymetrix' "expectations," "beliefs," "hopes," "intentions," "strategies," or the like. Such statements are subject to risks and uncertainties that could cause actual results to differ materially for Affymetrix from those projected, including, but not limited to: uncertainties relating to the commercial and technological success of the agreement between Epigenomics and Affymetrix discussed in this press release; risks of the Company's ability to achieve and sustain higher levels of revenue, higher gross margins, reduced operating expenses; uncertainties relating to technological approaches, manufacturing (including risks related to the Company's ability to achieve hoped-for manufacturing yields for certain array products, including the ability to identify and resolve manufacturing problems), product development; personnel retention; uncertainties related to cost and pricing of Affymetrix products; dependence on collaborative partners; uncertainties relating to sole source suppliers; uncertainties relating to FDA and other regulatory approvals; competition; risks relating to intellectual property of others and the uncertainties of patent protection and litigation. These and other risk factors are discussed in Affymetrix' Form 10-K for the year ended December 31, 2005, and other SEC reports, including its Quarterly Reports on Form 10-Q for subsequent quarterly periods. Affymetrix expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Affymetrix' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
NOTE: Affymetrix, the Affymetrix logo, and GeneChip are registered trademarks owned or used by Affymetrix Inc.
Disclaimer
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.