Affymetrix®, Inc. (NASDAQ:AFFX) announced today that it has entered into an exclusive, worldwide licensing agreement with Genisphere®, LLC, for RNA amplification and labeling technology to address challenging sample types including formalin-fixed, paraffin-embedded (FFPE) samples for GeneChip® Arrays.

These FFPE samples, common in cancer and translational research, are an untapped resource of valuable data for academic, pharmaceutical, and biotechnology researchers using microarrays to discover biomarkers and clinically relevant gene expression profiles to advance the understanding of diseases.

This technology, currently supplied by Genisphere to Pathwork® Diagnostics for their FDA-cleared, gene expression-based Tissue-of-Origin Test, gives researchers access to the estimated 400 million archived normal and tumor FFPE samples that can be tapped for research and retrospective clinical trials. “The Genisphere RampUp™ Kit enables us to routinely and reliably analyze clinical FFPE tissue biopsy specimens, many which contain very limited amounts of tissue,” said W. David Henner, MD, PhD, and Chief Medical Officer at Pathworks Diagnostics.

“Extracting the maximum available content from FFPE and other clinical samples required a unique solution to a complex problem wrapped in a simple, easy-to-use package. Building upon our proven RampUP product line, Genisphere optimized the process and enhanced fidelity, yielding a streamlined RNA amplification product that outperforms other competitive platforms,” said Bob Getts, Vice President of Research and Development at Genisphere.

Affymetrix branded kits will be available in 2012. The affordable kits will provide an easy-to-use workflow, higher sensitivity, and better reproducibility than other currently available solutions for FFPE RNA analysis. Combined with the most widely cited microarrays, including the GeneChip® Human Genome U133 2.0 Array and whole-transcriptome gene arrays from Affymetrix, this solution provides a powerful new tool for gene expression analysis of clinically relevant FFPE samples.

“This agreement advances the Affymetrix vision of growing our microarray business within targeted applications where array-based approaches provide more cost-effective solutions, highly accurate data, and the most relevant gene expression content compared to competing technologies,” said Kevin Cannon PhD, General Manager of the Gene Expression Business Unit at Affymetrix. “In today’s competitive market, it is critical to provide researchers with the right tool for the specific application. The strategic addition of Genisphere’s RNA amplification and labeling solution for FFPE samples is a perfect complement to the Affymetrix microarray portfolio, providing researchers a complete workflow solution from whole-genome analysis of clinically challenging FFPE samples to validation of single genes using our QuantiGene® Assay portfolio of products.”

About Affymetrix

Affymetrix technology is used by the world's top pharmaceutical, diagnostic, and biotechnology companies as well as leading academic, government, and nonprofit research institutes. More than 2,100 systems have been shipped around the world, and more than 24,000 peer-reviewed papers have been published using the technology. Affymetrix is headquartered in Santa Clara, CA, and has manufacturing facilities in Cleveland, Ohio, and Singapore. The company has about 900 employees worldwide and maintains sales and distribution operations across Europe, Asia, and Latin America. For more information about Affymetrix, please visit http://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. These and other risk factors are discussed in Affymetrix' Form 10-K for the year ended December 31, 2010, and other SEC reports for subsequent quarterly periods.

NOTE: Affymetrix, and the Affymetrix logo, are trademarks or registered trademarks of Affymetrix, Inc.

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