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Affymetrix Inc. (Nasdaq:AFFX) and Marshfield Clinic today announced that
researchers at Marshfield Clinic used the Affymetrix Drug Metabolizing
Enzymes and Transporters (DMET) solution to discover a genetic variation
associated with an individual’s response to
the drug warfarin.
The study, “CYP4F2 genetic variant alters
required warfarin dose,” was published this
week by Blood Online. The results of the study could help reduce
much of the serious adverse events caused by incorrect warfarin dosage
and enable doctors to treat patients with a more effective, personalized
form of medicine.
The team of scientists, led by Michael D. Caldwell, M.D., Ph.D., of
Marshfield Clinic, discovered a genetic variation in a gene called
CYP450 4F2 (CYP4F2) that explains approximately 8 percent of a patient’s
variable response to warfarin. The discovery was made possible because
of the DMET solution, which is the industry’s
most comprehensive method for assaying the genetics of drug metabolism.
Marshfield has already begun testing the result in a prospective Phase
III clinical trial expected to be completed by the end of 2008 and
funded by the Agency for Healthcare Research and Quality (AHRQ).
“This discovery should enable us to better
predict a stable therapeutic dose and hopefully reduce the overall
complications of warfarin therapy,” said Dr.
Caldwell. “Understanding the factors and
genetic variations that affect the metabolization of drugs gives doctors
a much more accurate idea of how best to treat patients. The nation’s
entire healthcare system can benefit from these types of advances.”
In August 2007, the U.S. Food and Drug Administration (FDA) announced
that they would be updating the labeling of warfarin with known valid
markers in the CYP2C9 and VKORC1 genes to provide information on how an
individual’s genetics may impact their
response to the drug. The use of warfarin is complicated due to its
small therapeutic index window of dosage. If a dose is too high, there
is a risk of bleeding; if a dose is too low, the drug will be
ineffective and there may be a risk of clotting. The optimum dosage is
affected by factors such as genetics, age, body mass index and gender.
“Marshfield Clinic has one of the world’s
largest and best characterized patient populations for warfarin
treatment and we are thrilled to collaborate with them to help solve
this dosing problem,” said Maneesh Jain,
senior director of marketing at Affymetrix. “This
study is an example of the power and ability of our DMET solution.
Clinical researchers are now able to take a comprehensive look at all of
the drug metabolism biomarkers, which will enable clinicians and
pharmaceutical scientists to develop safer and more effective treatments.”
In January, Affymetrix launched its DMET Early Access solution, an
updated version of the assay used in the Marshfield warfarin study.
Pharmaceutical customers are using the DMET solution to better
understand pharmacokinetics, the study of the bodily absorption,
distribution, metabolism and excretion (ADME) of drugs. DMET is the only
product available with comprehensive coverage of all ADME drug
metabolism biomarkers. It profiles more than 1,069 drug metabolism
biomarkers, including 172 “core”
genetic markers. Data is automatically interpreted into a common format
that can be integrated into clinical trial workflows. The information
enables researchers to make more informed drug-development decisions,
which in turn significantly streamlines the drug-development process
and, therefore, the time to market.
For more information the Affymetrix DMET Early Access Solution, please
visit: http://www.affymetrix.com/genechip/DMET.affx
About Marshfield Clinic
The Marshfield Clinic system provides patient care, research and
education with more than 40 locations in northern, central and western
Wisconsin, making it one of the largest comprehensive medical systems in
the United States. For more information about Marshfield Clinic, visit: http://www.marshfieldclinic.org
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 1,600 systems have been shipped around the world and more than
10,500 peer-reviewed papers have been published using the technology.
Affymetrix is headquartered in Santa Clara, Calif., and has
manufacturing facilities in Sacramento, Calif., Cleveland, Ohio, 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: 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
relating to commercial success of the collaboration between Affymetrix
and Marshfield Clinic discussed in this press release; risks of the
company’s ability to achieve and sustain
higher levels of revenue, risks related to past and present
acquisitions, 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; risks
associated with acquisitions; 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, 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.