Affymetrix Achieves ISO Certification for Instrumentation and Microarray Manufacturing Facilities
August 31 2004 - 4:01AM
PR Newswire (US)
Affymetrix Achieves ISO Certification for Instrumentation and
Microarray Manufacturing Facilities -- Certification Marks Critical
Milestone on Path to Diagnostic Products in European Marketplace --
SANTA CLARA, Calif., Aug. 31 /PRNewswire-FirstCall/ -- Affymetrix,
Inc., (NASDAQ:AFFX) today announced that both its instrument and
microarray manufacturing facilities, located in Bedford, MA and
West Sacramento, CA, respectively, have been audited by TUV America
and have received ISO certification. The achievement of ISO
certification confirms that quality systems have been implemented
in product development, operations, shipping, and service and will
support CE marking of future Affymetrix products that will be
labeled for in-vitro diagnostic use for sale within the European
Community. "Affymetrix takes pride in its commitment to delivering
the highest-quality microarray products manufactured for the life
sciences business," said Rob Lipshutz, Senior Vice President of
Molecular Diagnostics and Emerging Markets at Affymetrix. "This
certification recognizes our ability to deliver high quality
products to the diagnostics market and represents an important
component required for regulated diagnostic products." Affymetrix
technology has been used in nearly 3,000 scientific publications to
discover the basic underpinnings of diseases such as cancer,
multiple sclerosis, and numerous developmental disorders. ISO
certification represents an important step in developing new
array-based diagnostic tools that will more directly impact the
patient, enabling physicians to stratify disease, predict outcome,
and make therapeutic choices in ways never before possible. A
growing community of businesses have partnered with Affymetrix to
develop diagnostic microarray products for both clinical and
non-clinical markets. Instrumentation and microarrays manufactured
in Affymetrix' ISO compliant facilities will be made available to
these "Powered by Affymetrix" partners in order to accelerate the
design and launch of future diagnostic systems in the European
Union. Under terms of the "Powered by Affymetrix" program,
Affymetrix manufactures the microarrays and instruments, while the
diagnostic partner develops and commercializes the test. The
resulting microarray products enable users to examine genomic
sequences in more detail than ever before, providing a more
efficient and complete method to diagnose a wide range of
conditions and create potential solutions. 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(R) 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, manufacturing, product development
(including uncertainties relating to the development of diagnostic
products), 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 Contact: Wes Conard, Assoc.
Director, Public Relations, +1-408-731-5791, or +1-415-385-4455; or
Investor Contact: Doug Farrell, Vice President, Investor Relations,
+1-408-731-5285 Web site: http://www.affymetrix.com/
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