30.05.2008 12:00:00

Affymetrix Technology Powers First Genomic Tumor Grading Test for Breast Cancer

Affymetrix Inc. (Nasdaq: AFFX) today announced that its technology powers the Ipsogen MapQuant Dx™ Genomic Grade, the first genomic test designed to provide a more precise measurement of tumor grade than previous techniques. Ipsogen, a leading French molecular diagnostic company, today launched the test, which resulted from the Powered by Affymetrix™ agreement signed in August 2007. Affymetrix is the only company to offer a continuous path to discover, develop and commercialize complex biomarker signature assays. The company partners with leading diagnostic companies such as Ipsogen through its Powered by Affymetrix™ (PbA) program. The company features the only microarray instrumentation platform to receive regulatory clearance by the U.S. FDA and to be 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. There are currently more than 20 different molecular assay tests based on the Affymetrix platform under development by Affymetrix and its 11 PbA partners. "The Affymetrix technology enables us to address clinicians’ needs by translating the genomic profile of each tumor into reliable, intelligible and decisive information for pathologists, oncologists and patients,” said Vincent Fert, president and chief executive officer of Ipsogen. "Extracting the grade from the confusing field of prognostic factors gives us a much better chance of offering timely treatment to women suffering from breast cancer.” "Affymetrix is proud to partner with molecular diagnostic innovators like Ipsogen to produce microarray-based tools that can substantially improve healthcare decisions for the millions of women suffering from breast cancer,” said Kevin King, president of Affymetrix. "The MapQuant Dx™ Genomic Grade is the first diagnostic test resulting from our Powered by Affymetrix™ (PbA) agreement with Ipsogen. We look forward to the continued success of this test and future projects.” Tumor grade is a key indicator of malignancy and a more accurate measurement could help guide and improve oncologists’ decisions. In many cases, the grade determines the type of treatment: "grade-3” tumors require chemotherapy, while "grade-1” tumors are treated only with hormonotherapy. With traditional grading techniques, almost 50 percent of tumors are classified in the intermediate "grade-2” category, which makes treatment decisions more difficult. As a precaution, "grade-2” tumors are often treated with chemotherapy, even though that could have been avoided in many cases. The MapQuant Dx™ Genomic Grade is a unique molecular test aimed at standardizing and quantifying the grading of breast carcinomas. Based on a 97-gene expression signature of the tumor, the test provides a more precise and accurate measurement than previous grading techniques. In one recent study, the Genomic Grade test was used to reclassify 70 percent of previously identified "grade-2” node-negative hormone-sensitive breast cancer patients as "lower-risk” patients who could avoid chemotherapy.1 About MapQuant Dx™ Genomic Grade The MapQuant Dx™ Genomic Grade uses the Genomic Grade technologies, for which Ipsogen has signed a license agreement for worldwide exclusive rights with Université Libre de Bruxelles (ULB), Belgium. The Genomic Grade is a gene expression index invented by oncology researchers from the Bordet Institute, Brussels, and the Swiss Institute for Cancer Research (ISREC), Lausanne, two leading European cancer research institutes. About Ipsogen Ipsogen is a cancer profiler that develops and markets molecular diagnostic assays designed to map diseases and guide patients’ and clinicians’ decisions along the complex therapeutic path. With more than 60 tests already used routinely worldwide for the diagnosis, prognosis and follow-up of thousands of patients with leukemia, Ipsogen is now also targeting breast cancer. Its initial goal will be to provide diagnostic information that has been inaccessible until now. Ipsogen is also a partner of choice for biopharmaceutical companies committed to revolutionary theranostics. Strengthened by its first-rate scientific, clinical and technological partnerships, in addition to its highly skilled multidisciplinary teams in France and the United States, Ipsogen is striving to become the leader in the molecular profiling of cancers. It is pursuing its development and promotion of diagnostic standards that have a significant impact on patients, the medical profession and society in general. Ipsogen employed 40 people as of April 30, 2008. Its headquarters are located in Marseille, France. The company also has a subsidiary, Ipsogen Inc., in New Haven, Connecticut, U.S. Find out more at www.Ipsogen.com About Affymetrix Affymetrix GeneChip® microarray technology is the industry-standard tool for analyzing complex genetic information. After inventing microarray technology in the late 1980s, Affymetrix scientists have been dedicated to developing innovative products that provide researchers with a more complete view of the genome. These products continue to accelerate genetic research and enable scientists to develop diagnostics and tailor treatments for individual patients by identifying and measuring the genetic information associated with complex diseases. Today, 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 1,700 systems have been shipped around the world and more than 12,000 peer-reviewed papers have been published using the technology. Affymetrix is headquartered in Santa Clara, Calif., and has manufacturing facilities in Sacramento, Calif., Cleveland, Ohio, and Singapore. The company has about 1,100 employees worldwide and maintains sales and distribution operations across Europe and Asia. For more information about Affymetrix, please visit the company’s website at www.affymetrix.com. Forward-looking Statements 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: risks and uncertainties relating to commercial success of the agreement with Ipsogen discussed in this press release; risks of the company’s ability to achieve and sustain higher levels of revenue, higher gross margins and reduced operating expenses; uncertainties related to technological approaches, manufacturing and product development; personnel retention; uncertainties related to cost and pricing of Affymetrix products; dependence on collaborative partners; uncertainties related to sole-source suppliers; risks associated with past and future acquisitions; 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, 2007, 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. 1 Loi S., et al. Definition of Clinically Distinct Molecular Subtypes in Estrogen Receptor–Positive Breast Carcinomas through Genomic Grade. Journal of Clinical Oncology (2007), Vol. 25, Issue No. 10, 1239-1246

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