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Affymetrix and Sysmex Join Forces to Develop and Market In-Vitro Diagnostic Tests

Business Wire, Dec 13, 2006

SANTA CLARA, Calif. -- Affymetrix Inc. (Nasdaq:AFFX) announced today that it has signed two agreements with Sysmex Corporation of Kobe, Japan, to distribute, develop and market in-vitro diagnostic tests. A Clinical Development and Marketing Agreement grants Sysmex exclusive rights to distribute Affymetrix' diagnostic microarray products and instrumentation in Japan with the opportunity to expand into certain Asia Pacific countries. In addition, a Powered by Affymetrix[TM] agreement gives Sysmex non-exclusive access to Affymetrix microarray technology to develop and market in-vitro diagnostic tests on a worldwide basis.

Sysmex will carry out all registration, sales and customer support activities for the diagnostic instrumentation, array and reagent products as the Affymetrix distributor for Japan. Sysmex is a global leader in diagnostic systems for hematology, coagulation and immunochemistry testing. The company has recently launched a system for detection of breast cancer lymph node metastasis.

The Powered by Affymetrix agreement enables Sysmex to incorporate Affymetrix' patented arrays into its diagnostic products. It is expected that the resulting microarray-based tests will enable clinicians to provide more efficient and complete methods to diagnose, classify and manage these disorders.

"We are very pleased that Sysmex, with its strong reputation for product quality and customer support, will represent our growing line of diagnostic products in such an important region of the world," said Noel Doheny, senior vice president, Molecular Diagnostics at Affymetrix. "Sysmex shares our vision of enabling the personalization of medicine through high-value, content-rich tests. We look forward to working with them as part of our Powered by Affymetrix program to create microarray-based tools and applications that will support efficacious disease management."

The Affymetrix line of diagnostic products 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. Affymetrix, as well as its Powered by Affymetrix partners, are developing array-based tests for use with this system.

About Sysmex:

Sysmex Corporation, headquartered in Kobe, Japan, has been developing and manufacturing laboratory diagnostic systems for hematology as well as for hemostasis, immunochemistry and urinalysis since 1968, and is a global market leader in integrated laboratory automation. The company has built a strong leadership worldwide. Sysmex has earned an excellent reputation among medical institutions around the world by combining technological excellence with the capability to propose solutions that precisely meet customer needs. Sysmex currently seeks to leverage its extensive business infrastructure to achieve further growth and increase corporate value by expanding its business domain beyond diagnosis and treatment to encompass the broader healthcare field that includes disease prevention and health maintenance. We will fuse original technologies developed in the diagnostics field and new technologies in the life science field and take up the challenge of entering new business fields. In addition, we will continue to provide high-value-added products and services that contribute to improving the quality of life for people everywhere. This is the unchanging corporate posture of Sysmex. Additional company information is available on the Internet at www.sysmex.com.

About Affymetrix:

Affymetrix scientists invented the world's first high-density 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 more than 7,000 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 manufacturing facilities in Sacramento, Calif., and Bedford, Mass. The company maintains important sales and marketing operations in Europe and Asia, and has about 1,100 employees worldwide. For more information about Affymetrix, please visit the company's website 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: risks and uncertainties associated with the agreement between Affymetrix and Sysmex 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 relating to technological approaches, manufacturing and 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/A 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.


 

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