Affymetrix Begins Shipment of Industry’s First FDA-cleared Gene Profiling Reagents
July 12 2011 - 4:45AM
Business Wire
Affymetrix, Inc. (NASDAQ:AFFX) today began shipping its
FDA-cleared Gene Profiling Reagents. Affymetrix also announced the
availability of the new Gene Profiling Array cGMP U133 P2, a
version of the widely cited Human Genome U133 Plus 2.0 Array, as
another component to its GeneChip® Instrument System, which is used
by Affymetrix partners for assay development.
To accelerate test development cycles, the new tools are
manufactured and quality controlled under current good
manufacturing practices (cGMP) and ISO 13485 standards.
Additionally, with an instrument platform and reagents that are
FDA-cleared for in vitro diagnostic (IVD) use and CE-marked as IVD
medical devices for sale in the European Union, the Affymetrix
clinical toolkit eases the regulatory burden.
Affymetrix clinical applications, along with its Powered by
Affymetrix™ (PbA) partner program, are enabling major development
and commercialization milestones for molecular diagnostic tests in
cancer diagnostics, blood and tissue-based screening, and disease
segmentation. The PbA partners are at various stages of development
and commercialization of microarray-based tests; three diagnostic
tests, the Roche AmpliChip® CYP450 Test, Pathwork® Tissue of Origin
Test, and AMLprofiler™, are already CE-IVD or FDA-cleared, and more
than ten tests are moving toward CE-IVD or nearing FDA
submission.
“From a regulatory point of view, developing our standardized
microarray-based AMLprofiler for diagnosing acute myeloid leukemia
using Affymetrix instrumentation, reagents, and arrays is
absolutely essential, and the IVD reagents are therefore a central
component of the product,” said Dr. Henk Viëtor, MD, PhD, and Chief
Executive Officer of Skyline Diagnostics BV, a Netherlands-based
companion diagnostics pioneer and PbA partner. Most recently,
Skyline received a CE-IVD mark for its acute myeloid leukemia test
and announced a research and development agreement for companion
diagnostics with Janssen, a pharmaceutical division of Johnson
& Johnson.
“The key element is that Affymetrix provides the tools to make
it easy for us to concentrate on the content,” Dr. Viëtor
emphasized. “Now, everything is fully covered, from signature
discovery, to clinical application, to routine testing — a complete
cycle for FDA-cleared and registered products.”
Among other recent PbA milestones is the Medicare reimbursement
status achieved by Pathwork Diagnostic, Inc. for its Pathwork®
Tissue of Origin Test, the first and only FDA-cleared
expression-based microarray for tissue of origin for malignant
tumor types. Additionally, Almac Diagnostics received Clinical
Laboratory Improvement Amendment (CLIA) Certification for a new lab
in France to support the company's biomarker discovery and
development strategy. Also, Signature Diagnostics AG, developers of
the Detector C colorectal non-invasive cancer screening test,
announced a major market expansion in Germany’s IVD healthcare
market.
“We are filling a growing demand for a complete gene expression
solution that meets stringent U.S. and E.U. regulatory and
manufacturing requirements for clinical test commercialization,”
said Andy Last, PhD, Chief Commercial Officer at Affymetrix. “Our
clinical toolkit and PbA partner program give clinical researchers
a proven path from biomarkers to market.”
Affymetrix PbA partners, in addition to Pathwork, Almac,
Signature, and Skyline, include Roche, TessArae, Ipsogen, and
Veridex.
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
2,100 systems have been shipped around the world and more than
23,600 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, 2010, 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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