AFFX Affymetrix, Inc.

Affymetrix Achieves ISO Certification for Instrumentation and Microarray Manufacturing Facilities -- Certification Marks Critical Milestone on Path to Diagnostic Products in European Marketplace -- SANTA CLARA, Calif., Aug. 31 /PRNewswire-FirstCall/ -- Affymetrix, Inc., (NASDAQ:AFFX) today announced that both its instrument and microarray manufacturing facilities, located in Bedford, MA and West Sacramento, CA, respectively, have been audited by TUV America and have received ISO certification. The achievement of ISO certification confirms that quality systems have been implemented in product development, operations, shipping, and service and will support CE marking of future Affymetrix products that will be labeled for in-vitro diagnostic use for sale within the European Community. "Affymetrix takes pride in its commitment to delivering the highest-quality microarray products manufactured for the life sciences business," said Rob Lipshutz, Senior Vice President of Molecular Diagnostics and Emerging Markets at Affymetrix. "This certification recognizes our ability to deliver high quality products to the diagnostics market and represents an important component required for regulated diagnostic products." Affymetrix technology has been used in nearly 3,000 scientific publications to discover the basic underpinnings of diseases such as cancer, multiple sclerosis, and numerous developmental disorders. ISO certification represents an important step in developing new array-based diagnostic tools that will more directly impact the patient, enabling physicians to stratify disease, predict outcome, and make therapeutic choices in ways never before possible. A growing community of businesses have partnered with Affymetrix to develop diagnostic microarray products for both clinical and non-clinical markets. Instrumentation and microarrays manufactured in Affymetrix' ISO compliant facilities will be made available to these "Powered by Affymetrix" partners in order to accelerate the design and launch of future diagnostic systems in the European Union. Under terms of the "Powered by Affymetrix" program, Affymetrix manufactures the microarrays and instruments, while the diagnostic partner develops and commercializes the test. The resulting microarray products enable users to examine genomic sequences in more detail than ever before, providing a more efficient and complete method to diagnose a wide range of conditions and create potential solutions. About Affymetrix: Affymetrix is a pioneer in creating breakthrough tools that are driving the genomic revolution. By applying the principles of semiconductor technology to the life sciences, Affymetrix develops and commercializes systems that enable scientists to improve quality of life. The Company's customers include pharmaceutical, biotechnology, agrichemical, diagnostics and consumer products companies as well as academic, government and other non-profit research institutes. Affymetrix offers an expanding portfolio of integrated products and services, including its integrated GeneChip(R) brand platform, to address growing markets focused on understanding the relationship between genes and human health. Additional information on Affymetrix can be found at http://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 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, product development (including uncertainties relating to the development of diagnostic products), market acceptance, 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, 2003 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. DATASOURCE: Affymetrix, Inc. CONTACT: Media Contact: Wes Conard, Assoc. Director, Public Relations, +1-408-731-5791, or +1-415-385-4455; or Investor Contact: Doug Farrell, Vice President, Investor Relations, +1-408-731-5285 Web site: http://www.affymetrix.com/

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