Affymetrix Launches World's Most Comprehensive Solution for Clinical Drug Metabolism Studies
January 24 2008 - 8:00AM
Business Wire
Affymetrix Inc. (NASDAQ: AFFX) today announced the availability of
its Drug Metabolizing Enzymes and Transporters (DMET) Early Access
solution, currently the world�s most comprehensive method for
assaying the genetics of drug metabolism. The DMET offering
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, time to market. The
DMET solution is available as a service through Affymetrix� South
San Francisco Services Laboratory and Cogenics, a subsidiary of
Clinical Data (NASDAQ: CLDA). Both providers have been accepting
samples since the fourth quarter of 2007, following the successful
completion of a six-week training and certification program to
ensure that data is complete, accurate and reproducible. Cogenics
is offering DMET as a Good Laboratory Practice (GLP)-compliant
service from its North Carolina facility, while Affymetrix� South
San Francisco facility is running the service strictly for non-GLP
research studies. Additional worldwide service providers will be
certified and announced in the near future. Affymetrix and Clinical
Data announced a joint marketing agreement today in a separate
press release. 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, including common and rare
variations, insertions, deletions, copy number, triallelic SNPs and
pseudogenes. For the first time, scientists are able to assess all
clinically relevant ADME markers in a single assay, unlike
previously used single-plex approaches. �Being able to measure a
variety of �core� genetic markers is critical to delivering
accurate clinical assays, something the Affymetrix technology is
allowing us to achieve. Accurate clinical assays have the ability
to deliver improved patient outcomes because the medicines we
develop become more directly targeted to the patient's specific
needs," said Richard Deane Hockett, senior clinical research
physician, group leader for genomic medicine, Department of
Diagnostic and Experimental Medicine at Eli Lilly & Co. �We are
implementing this technology across the research portfolio in all
phases of clinical trials at Lilly.� Regulatory authorities have
indicated a renewed interest in surveying drug metabolism
biomarkers to ensure safer dosing, which in turn reduces the
possibility of adverse events and improves patient safety. Just
three months ago, the U.S. Food and Drug Administration (FDA) made
history by updating the label on the anticoagulant drug, Warfarin,
to include information on CYP2C9 and VKCORC1. According to a
commentary in Clinical Pharmacology and Therapeutics co-authored by
the FDA1, �Pharmacogenomic data can facilitate our understanding of
the sources of variability in drug response and can potentially
lead to improved safety and efficacy of drug therapy for individual
patients. Through various initiatives, the FDA is encouraging drug
developers to apply the rapidly evolving pharmacogenomic tools and
integrate these data into the evaluation of patient variability.�
Michael Caldwell, M.D., Ph.D., director of the Wound Healing
Program at Marshfield Clinic, has been using the DMET solution to
research the genetics behind an individual�s drug response to
Warfarin, a drug that if prescribed at the wrong dose can have
serious adverse events. �The DMET panel has allowed us to better
delineate the stable therapeutic dose of Warfarin for our patients
at the initiation of therapy, where risk of complications from the
drug are at their highest,� said Dr. Caldwell. �Thus our hope is
that these studies will enable us to reduce the overall
complications of Warfarin therapy by a better prediction of stable
therapeutic dose.� The DMET solution features easy-to-use patient
consent tracking and data translation software to identify
functional variants across the panel and to convert genotyping
results into standardized star nomenclature, a convention commonly
used in the genetic analyses of clinical trials. The automated
analysis takes only a few minutes to complete and provides
pharmaceutical researchers performing clinical trials with familiar
data that can be easily integrated into existing workflows.
Previously, this analysis was a manual and time-consuming task as
scientists were required to scour literature for relevant answers.
"DMET Early Access is the result of an ongoing Affymetrix
commitment to develop assays that are targeted at clinical drug
development,� said Maneesh Jain, senior director of marketing at
Affymetrix. �We've been fortunate to work with leading
pharmaceutical partners and key medical centers to design and
develop an assay that�s comprehensive for ADME biomarkers and
directly provides information with clinical utility.� 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., 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 Affymetrix DMET Early Access
Solution 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; risks associated
with past and future 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. NOTE: Affymetrix, the
Affymetrix logo and GeneChip� are registered trademarks owned or
used by Affymetrix Inc. 1 Andersson T., et al. Drug-metabolizing
enzymes: Evidence for Clinical Utility of Pharmacogenomic Tests.
Clinical Pharmacology and Therapeutics (2005) 78, 559�581
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