Affymetrix Microarray System Cleared by FDA
December 27 2004 - 7:30AM
PR Newswire (US)
Affymetrix Microarray System Cleared by FDA - The GCS 3000Dx System
is the first microarray system to be cleared by the FDA for
diagnostic testing - SANTA CLARA, Calif., Dec. 27
/PRNewswire-FirstCall/ -- Affymetrix Inc., (NASDAQ:AFFX) announced
today that the U.S. Food and Drug Administration (FDA) has granted
regulatory clearance for the Affymetrix GeneChip(R) System 3000Dx
(GCS 3000Dx), an instrumentation system to analyze in vitro
diagnostic (IVD) microarrays. This is the first microarray
instrument to be cleared by the FDA for IVD use, providing a
standardized platform for nucleic acid diagnostics. "The FDA's
decision is another milestone demonstrating Affymetrix' commitment
to clinical diagnostic products," said Stephen P.A. Fodor, Ph.D.,
Chairman and CEO of Affymetrix. "We can now offer our diagnostic
partners an FDA-cleared system to develop and commercialize
high-quality, reproducible diagnostic assays, such as Roche
Diagnostics' AmpliChip CYP450 Test which is currently offered in
the European Union." The FDA clearance of the Affymetrix GCS 3000Dx
follows the August ISO certification of the instrument and array
manufacturing facilities and the September IVD CE marking of the
instrument system in the European Union. Affymetrix will continue
to work with its Powered by Affymetrix(TM) partners to develop
genotyping and gene expression diagnostics on the GCS 3000Dx
system. Under the program, Affymetrix provides technology and
expertise for products that are developed, branded and marketed by
the diagnostic partners. The FDA's clearance of the GCS 3000Dx
system represents a major step toward the use of microarrays for
clinical applications. Since the early 1990s, Affymetrix
microarrays have become the industry-standard in medical research,
used in nearly 3,000 peer reviewed publications in areas such as
disease classification, mutation detection and gene expression
analysis. The detailed molecular snapshot that microarrays reveal
should provide clinicians with more accurate diagnoses and allow
for more effective treatments. About Affymetrix: Affymetrix is a
pioneer in creating breakthrough tools that are driving the genomic
revolution. By applying the principles of semiconductor technology
to the life sciences, Affymetrix develops and commercializes
systems that enable scientists to improve quality of life. The
Company's customers include pharmaceutical, biotechnology,
agrichemical, diagnostics and consumer products companies as well
as academic, government and other non- profit research institutes.
Affymetrix offers an expanding portfolio of integrated products and
services, including its integrated GeneChip brand platform, to
address growing markets focused on understanding the relationship
between genes and human health. Additional information on
Affymetrix can be found at 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 risks of the Company's ability to achieve and
sustain higher levels of revenue, higher gross margins, reduced
operating expenses, uncertainties relating to technological
approaches (including the use of Affymetrix instruments for use
with microarray diagnostics as discussed in this press release),
manufacturing, product development, market acceptance, personnel
retention, uncertainties related 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' Form 10-K for the year ended December 31,
2003 and other SEC reports, including its Quarterly Reports on Form
10-Q for subsequent quarterly periods. 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. NOTE:
Affymetrix, the Affymetrix logo, and GeneChip are registered
trademarks owned or used by Affymetrix, Inc. DATASOURCE: Affymetrix
Inc. CONTACT: Media, Irma Gomez-Dib, Public Relations
Representative, +1-415-706-9155, or Investors, Doug Farrell, Vice
President, Investor Relations, +1-408-731-5285, both of Affymetrix
Inc. Web site: http://www.affymetrix.com/
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