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Affymetrix Clinical Services Laboratory Receives CLIA Certification

Posted on: Monday, 23 April 2007, 09:00 CDT

Affymetrix Inc. (NASDAQ: AFFX) today announced that the Affymetrix Clinical Services Laboratory (ACSL) successfully passed the State of California survey for CLIA (Clinical Laboratory Improvement Amendments) certification on April 9, 2007. The State of California inspector gave ACSL permission to begin offering microarray-based molecular diagnostic patient and clinical trial testing services. These services are designed to improve healthcare and help customers develop personalized tests and therapies faster than ever before.

The Affymetrix-owned and --operated laboratory enables clinical and research laboratories, as well as diagnostic and pharmaceutical companies, to incorporate complex molecular tests into clinical practice. The CLIA certification ensures that all of its processes are standardized to consistently meet federal and Clinical Laboratory Standards Institute (CLSI) guidelines for accuracy, precision, sensitivity, calibration and control. In addition, all of the ACSL assays have been validated for clinical applications to help ensure reproducible results.

ACSL uses the industry-standard GeneChip® microarray platform, which is the only platform to have earned 510(k) clearance from the United States Food and Drug Administration and to have secured the CE mark from the European Union. A team of licensed and board-certified personnel processes all of the samples and manages data to help ensure the highest quality results.

"The Affymetrix GeneChip® System 3000Dx is the first microarray instrumentation system cleared for molecular diagnostic laboratories and it is becoming the platform of choice for clinical trials and clinical care," said Noel Doheny, senior vice president, molecular diagnostics business unit at Affymetrix. "ACSL will further facilitate this broad adoption of array-based diagnostic tests and help make personalized medicine a reality."

ACSL is a 10,000-square-foot facility located in West Sacramento, Calif., that opened in September 2006. Two customer agreements have already been signed to date and it is expected that the CLIA certification will enable a broader range of customers to utilize the facility. The laboratory specializes in patient testing and clinical trial services for gene expression monitoring, genotyping and chromosomal copy number analysis, as well as other molecular diagnostic tests. ACSL also prepares supporting documentation and offers training programs for customers looking to transfer the laboratory methods and apply validated protocols in their own regulated environments.

"ACSL enables customers to leverage Affymetrix' technology and experience to bring more effective molecular diagnostic tests to patients faster than ever before," said Cynthia French, vice president of ACSL. "We offer a number of services that will help accelerate the development of personalized tests and therapies."

For more information about the Affymetrix Clinical Services Laboratory, please send an email to diagnosticsales@affymetrix.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 1,500 systems have been shipped around the world and more than 8,500 peer-reviewed papers have been published using the technology.

Affymetrix is headquartered in Santa Clara, Calif., and has manufacturing facilities in Sacramento, Calif., 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 associated with the success of the Affymetrix Clinical Services Laboratory 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 for the year ended December 31, 2006, 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.

Source: Business Wire

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