SANTA CLARA, Calif.--(BUSINESS WIRE)--Affymetrix, Inc. (NASDAQ:AFFX) today announced that its GeneChip®System 3000Dx v.2 (GCS 3000Dx v.2) has been approved by China's State Food and Drug Administration (SFDA) for in vitro diagnostic use. The GCS 3000Dx v.2 is the first microarray instrument system to be granted SFDA registration for array-based diagnostics for enabling personalized medicine. China has more than 2,000 clinical centers that will now have access to the only SFDA-cleared microarray platform for clinical testing.
The molecular diagnostic market in China is the fastest growing in the world and represents a significant growth opportunity for Affymetrix in Asia. “We are delighted to be the first SFDA-cleared microarray platform, as this will enable us to expand into the clinical diagnostics applications,” says Chris Barbazette, Vice President, Commercial Operations International Markets at Affymetrix.
The GCS 3000Dx v.2 microarray platform has a proven record of successful development and commercialization through partnership via the Powered by Affymetrix™ (PbA) program. A number of companies are developing molecular diagnostic tests in cancer, cardiovascular diseases, and inherited disorders based on the Affymetrix GeneChip platform. More than ten tests are in the pipeline for regulatory clearance. Two FDA-cleared tests (Roche AmpliChip® CYP450 Test and Pathwork®Diagnostics' Tissue of Origin Test) and three CE-IVD marked tests, including Skyline Diagnostic’s AML test, are currently on the market. These tests and Affymetrix’ own solutions for cytogenetics, cancer, and pharmacogenomics are part of an increasing menu of clinical applications that can be run on the SFDA-cleared GeneChip System.
“Having an SFDA-cleared system and a wide-range of clinical tests will enable physicians in China to bring personalized medicine to their patients faster,” says Dr. Ming Zhang at Hangzhou Bio-San Biochemical Technologies Company.
“This registration clearance is a significant accomplishment for Affymetrix and supports our global clinical strategy. It connects us more closely to physicians in China wanting to utilize clinically relevant genomic biomarkers that improve their patients’ health and wellness,” said Andy Last, Executive Vice President of Genetic Analysis and Clinical Applications Business Unit at Affymetrix.
The GCS 3000Dx v.2 microarray System is cleared for in vitro diagnostic use in the United States, Japan, CE-IVD marked in Europe, and is also available in Canada, Singapore, Australia, India, and Saudi Arabia.
In addition to the GCS 3000Dx v.2, Affymetrix also offers a Clinical Toolkit, which contains the US FDA-cleared and CE-IVD marked Gene Profiling Reagents and the Gene Profiling Array cGMP U133 P2, the cGMP-manufactured version of the widely cited GeneChip® Human Genome U133 Plus 2.0 Array. The Affymetrix® Clinical Toolkit provides a proven path to market, enabling test developers to save time and money while reducing regulatory risks.
Affymetrix technology is used by the world's top pharmaceutical, diagnostic, and biotechnology companies as well as leading academic, government, and nonprofit research institutes. About 2,200 systems have been shipped around the world, and more than 25,000 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.
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: risk relating to the Company’s ability to successfully commercialize new products, risk relating to past and future acquisitions, including the ability of the Company to successfully integrate such acquisitions into its existing business; 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, risks associated with manufacturing and product development; personnel retention; uncertainties relating 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' Annual Report on Form 10-K for the year ended December 31, 2010, and other SEC reports. 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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Mindy Lee-Olsen, + 1 408-731-5523 (Media)
VP, Marketing Services
Doug Farrell, +1 408-731-5285 (Investor)
Vice President, Investor Relations