AFFX Affymetrix, Inc.

Affymetrix Microarray System Cleared by FDA - The GCS 3000Dx System is the first microarray system to be cleared by the FDA for diagnostic testing - SANTA CLARA, Calif., Dec. 27 /PRNewswire-FirstCall/ -- Affymetrix Inc., (NASDAQ:AFFX) announced today that the U.S. Food and Drug Administration (FDA) has granted regulatory clearance for the Affymetrix GeneChip(R) System 3000Dx (GCS 3000Dx), an instrumentation system to analyze in vitro diagnostic (IVD) microarrays. This is the first microarray instrument to be cleared by the FDA for IVD use, providing a standardized platform for nucleic acid diagnostics. "The FDA's decision is another milestone demonstrating Affymetrix' commitment to clinical diagnostic products," said Stephen P.A. Fodor, Ph.D., Chairman and CEO of Affymetrix. "We can now offer our diagnostic partners an FDA-cleared system to develop and commercialize high-quality, reproducible diagnostic assays, such as Roche Diagnostics' AmpliChip CYP450 Test which is currently offered in the European Union." The FDA clearance of the Affymetrix GCS 3000Dx follows the August ISO certification of the instrument and array manufacturing facilities and the September IVD CE marking of the instrument system in the European Union. Affymetrix will continue to work with its Powered by Affymetrix(TM) partners to develop genotyping and gene expression diagnostics on the GCS 3000Dx system. Under the program, Affymetrix provides technology and expertise for products that are developed, branded and marketed by the diagnostic partners. The FDA's clearance of the GCS 3000Dx system represents a major step toward the use of microarrays for clinical applications. Since the early 1990s, Affymetrix microarrays have become the industry-standard in medical research, used in nearly 3,000 peer reviewed publications in areas such as disease classification, mutation detection and gene expression analysis. The detailed molecular snapshot that microarrays reveal should provide clinicians with more accurate diagnoses and allow for more effective treatments. 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 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 (including the use of Affymetrix instruments for use with microarray diagnostics as discussed in this press release), manufacturing, product development, 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, Irma Gomez-Dib, Public Relations Representative, +1-415-706-9155, or Investors, Doug Farrell, Vice President, Investor Relations, +1-408-731-5285, both of Affymetrix Inc. Web site: http://www.affymetrix.com/

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