Affymetrix Achieves First FDA Clearance of Microarray-Based Gene Profiling Reagents
May 09 2011 - 4:45AM
Business Wire
Affymetrix, Inc. (NASDAQ:AFFX) today announced that the U.S.
Food and Drug Administration has cleared the addition of new gene
expression reagents as accessories to its GeneChip® Microarray
Instrument System for in vitro diagnostic (IVD) use, making
Affymetrix the first in the industry to provide a comprehensive
microarray-based clinical toolkit for diagnostic test development,
signature discovery for companion diagnostics, and translational
initiatives. Affymetrix® Gene Profiling Reagents offer unparalleled
convenience by simplifying assay workflow, decreasing hands-on
time, and reducing quality control testing compared to
research-use-only (RUO)-produced products. Use of the Gene
Profiling Reagents for clinical diagnostic test development should
lead to more consistent results and lower commercialization costs
for clinical providers and other Affymetrix customers.
With a full complement of arrays, assays, a data processing
solution, an instrument system, and reagents manufactured under
current Good Manufacturing Processes (cGMP) and ISO 13485
standards, the Affymetrix gene expression platform is the most
comprehensive and reliable system available for enabling the
development of clinical diagnostic tests. This industry-leading
system’s high standards aim to shorten development time by easing
the regulatory burden and delivering reproducible results.
“Affymetrix created the technology and marketplace for
multiplexed gene expression more than a decade ago, and this
clearance of our gene profiling reagent kit by the FDA marks
another milestone in our leadership in this important market
segment,” said Kevin King, President and Chief Executive Officer of
Affymetrix. “Thousands of research customers and Powered by
Affymetrix™ (PbA) Partners use our research products every day to
identify signatures or expression patterns that may lead to a
cancer diagnostic or an improved therapy determination for
patients. These customers can now seamlessly migrate from basic
signature discovery to validation on a robust system.”
The Affymetrix gene expression instrument platform has a
well-established record of successful development and
commercialization through its PbA partners, and is already in use
with two FDA-cleared tests, the Roche AmpliChip® CYP450 Test and
Pathwork® Diagnostics’ Tissue of Origin Test. Skyline Diagnostics
B.V. also used the platform to develop its AMLprofiler™ molecular
diagnostic assay, which is CE marked for IVD use in the EU and will
be submitted to the FDA. Additional tests are in the pipeline.
“Customers who are commercializing products on the Affymetrix
clinical platform can rely on our proven technology, global
distribution, services, and support organization,” said Affymetrix
Chief Commercial Officer Andy Last. “Affymetrix is leading the
industry into the era of personalized medicine by turning our
knowledge about biology, genes, and disease into tangible clinical
applications, and ultimately, into diagnostic decisions that
improve quality of life.”
Central to the Affymetrix expression platform is the Gene
Profiling Array, the cGMP-manufactured version of the widely cited
GeneChip® Human Genome U133 Plus 2.0 Array, along with the custom
signature arrays built from the HG-U133 Plus 2.0 Array. The Gene
Profiling Array is scientifically validated by more than 3,000
clinical publications, and users will have access to the largest
gene expression research database available for signature
development.
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. More than
2,000 systems have been shipped around the world and more than
23,000 peer-reviewed papers have been published using the
technology. Affymetrix is headquartered in Santa Clara, Calif., and
has manufacturing facilities in Santa Clara, Cleveland, Ohio, and
Singapore. The company has about 900 employees worldwide and
maintains sales and distribution operations across Europe and Asia.
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. These and
other risk factors are discussed in Affymetrix’ Form 10-K for the
year ended December 31, 2009, and other SEC reports for subsequent
quarterly periods.
NOTE: Affymetrix, the Affymetrix logo, GeneChip, and Powered by
Affymetrix are trademarks or registered trademarks of Affymetrix,
Inc.
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