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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