Marshfield Clinic Research Team Uses Affymetrix DMET Solution to Discover Genetic Variant Affecting Warfarin Metabolism in Patie
08 February 2008 - 12:00AM
Business Wire
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.
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