China Clears Its First Microarray Platform for in Vitro Diagnostics to Accelerate Personalized Medicine
February 15 2012 - 5:00PM
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.
About Affymetrix
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.
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: 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.
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