16.07.2007 12:00:00
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Affymetrix Clinical Services Laboratory and DOCRO Join Forces to Accelerate the Commercialization of In Vitro Diagnostic Products
Affymetrix Inc. (Nasdaq:AFFX) announced today that the Affymetrix
Clinical Services Laboratory (ACSL) has signed a co-marketing agreement
with DOCRO Inc., a leading contract research organization (CRO) that
specializes in the commercialization of in vitro diagnostic (IVD)
biomarker technologies. The two companies will work together to help
customers gain clearance or approval of IVD products from the U.S. Food
and Drug Administration (FDA) and bring those products to market faster
than before.
Over the past decade, there have been hundreds of microarray discoveries
-- expression and genotyping -- with potential diagnostic implications.
However, researchers have not had effective or efficient means to
translate these discoveries into validated clinical diagnostic tests.
With more than 80 FDA submissions, DOCRO is an experienced CRO that
provides ACSL customers with a clear path and understanding of how to
commercialize IVD products.
ACSL is a CLIA (Clinical Laboratory Improvement Amendments)-registered
clinical testing laboratory that offers microarray-based molecular
diagnostic send-out and clinical trial testing services to
pharmaceutical companies, IVD companies and other laboratories. The
co-marketing agreement with DOCRO provides ACSL customers with access to
a full suite of validation and regulatory clinical trial services and
resources. These include:
protocol design
patient recruitment
clinical site training and monitoring
clinical sample procurement
predicate device testing
guidance through the regulatory submission process
"DOCRO welcomes the opportunity to collaborate
with Affymetrix through its CLIA laboratory, ACSL,”
said Thomas F. Soriano, president and CEO of DOCRO. "For
the past 10 years, DOCRO has a proven formula for success that has led
to an unparalleled track record with the FDA, making DOCRO the clear
choice for FDA pre-market approvals. Together with Affymetrix, we can
expedite the commercialization process of ACSL customers’
products.” "We are very excited to work with the highly
experienced and enthusiastic team at DOCRO,”
said Cynthia French, Ph.D., vice president of ACSL. "Together,
we will enable our customers to bring more effective molecular
diagnostic tests to patients faster than ever before.” About ACSL
ACSL is a CLIA-registered clinical testing laboratory that specializes
in send-out and clinical trial testing services for gene expression
monitoring, genotyping and chromosomal copy number analysis, as well as
other molecular diagnostic tests. ACSL also prepares supporting
documentation and offers training programs for customers looking to
transfer the laboratory methods and apply validated protocols in their
own regulated environments. ACSL is located in a 10,000-square-foot
facility in West Sacramento, Calif.
For more information about the Affymetrix Clinical Services Laboratory,
please send an email to diagnosticsales@affymetrix.com.
About DOCRO
DOCRO is headquartered in Seymour, Connecticut, and has been servicing
the IVD industry for more than 10 years. DOCRO is a specialty CRO that
provides a full range of professional services to biotechnology,
therapeutic, pharmaceutical manufacturers and IVD manufacturers.
DOCRO’s services include strategic
consulting, product development, specimen acquisition and regulatory
consulting. DOCRO owns a CLIA-certified laboratory that offers a full
suite of clinical trial testing services.
With more than half of the IVD pre-market approvals during the past
decade, DOCRO has demonstrated its expertise and real-world experience
in the development, clinical validation and market-making introduction
of many of the then innovative, but now standard, diagnostic tests in
the field of oncology. DOCRO has in-depth experience with a wide variety
of protein-based and molecular biology-based diagnostic tests. Beyond
its traditional core specialty of oncology diagnostics, DOCRO has worked
extensively in the validation and regulatory submission process
involving infectious diseases, perinatal and prenatal disease,
cardiology, endocrinology, metabolic diseases, obstetrics and
gynecology, hematology/coagulation, transplant immunology, drugs of
abuse, and other medical specialties. For more information about DOCRO,
please visit the company’s website at www.docro.com.
About Affymetrix
Affymetrix GeneChip® microarray
technology is the industry-standard tool for analyzing complex genetic
information. After inventing microarray technology in the late 1980s,
Affymetrix scientists have been dedicated to developing innovative
products that provide researchers with a more complete view of the
genome. These products continue to accelerate genetic research and
enable scientists to develop diagnostics and tailor treatments for
individual patients by identifying and measuring the genetic information
associated with complex diseases.
Today, Affymetrix technology is used by the world’s
top pharmaceutical, diagnostic and biotechnology companies, as well as
leading academic, government and not-for-profit research institutes.
More than 1,500 systems have been shipped around the world and more than
8,500 peer-reviewed papers have been published using the technology.
Affymetrix is headquartered in Santa Clara, Calif., and has
manufacturing facilities in Sacramento, Calif., and Singapore. The
company has about 1,100 employees worldwide and maintains sales and
distribution operations across Europe and Asia. For more information
about Affymetrix, please visit the company’s
website at 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: risks and uncertainties
related to the agreement between Affymetrix and DOCRO discussed in this
press release; risks of the company’s ability
to achieve and sustain higher levels of revenue, higher gross margins
and reduced operating expenses; uncertainties related to technological
approaches, manufacturing and product development; personnel retention;
uncertainties related to cost and pricing of Affymetrix products;
dependence on collaborative partners; uncertainties related to
sole-source suppliers; uncertainties related to FDA and other regulatory
approvals; competition; risks related 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, 2006, 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. DOCRO and the
DOCRO logo are registered trademarks owned or used by DOCRO Inc.
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