Affymetrix GeneChip® System 3000Dx v.2
approved by SFDA for molecular diagnostics
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
AmpliChip® CYP450 Test and Pathwork®
Diagnostics' Tissue of Origin Test) and three CE-IVD marked tests,
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
"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.
PLEASE NOTE: Affymetrix, the Affymetrix logo, GeneChip, and all
other trademarks are the property of Affymetrix, Inc.
Mindy Lee-Olsen, + 1 408-731-5523 (Media)
Farrell, +1 408-731-5285 (Investor)
Vice President, Investor