SANTA CLARA, Calif.--(BUSINESS WIRE)--Affymetrix Inc. (Nasdaq:AFFX - News) announced today that the U.S. Food and Drug Administration (FDA) has granted regulatory clearance to its GCS3000Dx (GCSDx) platform for in vitro gene expression diagnostic testing. The microarray system was granted clearance along with the Pathwork® Tissue of Origin (TOO) Test from Pathwork Diagnostics Inc. This test analyzes a tumor’s gene expression profile to aid in diagnosing the source of hard-to-identify tumors and is the first of its kind to receive FDA clearance.
Pathwork is a member of the Powered by Affymetrix™ (PbA) program, which includes 11 leading diagnostic companies. There are currently more than 20 different molecular assay tests based on the Affymetrix platform under development by Affymetrix and its PbA Partners.
“We decided to work with Affymetrix because it is the market leader in gene expression testing research and its 510(k)-cleared microarray platform enabled us to develop a robust diagnostic,” said Deborah J. Neff, president and chief executive officer of Pathwork Diagnostics. “The FDA’s clearance of the Pathwork Tissue of Origin Test reaffirms the importance of genomics and the role microarray-based diagnostics can play in the battle against cancer.”
“Together Affymetrix and Pathwork have developed and now bring to market a very powerful tool to potentially improve cancer diagnostics and subsequent treatment planning and outcome,” said Kevin King, president of Affymetrix. “The Pathwork Tissue of Origin Test is supported by extensive analytical and clinical validation data. This not only expands the menu on our diagnostic platform, but opens the door for other gene expression-based diagnostic tests that are currently being developed by Affymetrix and our PbA partners on the GCSDx platform.”
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 1,700 systems have been shipped around the world and more than 13,000 peer-reviewed papers have been published using the technology.
Affymetrix is headquartered in Santa Clara, Calif., and has manufacturing facilities in Sacramento, Calif., Cleveland, Ohio, 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 relating to commercial success of the Pathwork® Tissue of Origin Test from Pathwork Diagnostics Inc. 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 related to technological approaches, manufacturing and product development; personnel retention; uncertainties related to cost and pricing of Affymetrix products; dependence on collaborative partners; uncertainties related to sole-source suppliers; risks associated with past and future acquisitions; 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, 2007, 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. Pathwork, Pathwork Diagnostics and the Pathwork Diagnostics logo are trademarks or registered trademarks of Pathwork Diagnostics Inc. Other names may be the trademarks of their respective owners.
Contact:
Affymetrix Inc. Media: Andrew Noble, 408-731-5571 Assistant Director, Corporate Communications or Investor: Doug Farrell, 408-731-5285 Vice President, Investor Relations
Source: Affymetrix Inc.
