Thursday November 6 9:00 AM EST
Company Press Release
Affymetrix Launches GeneChip(R) Polymorphism Cytochrome P450 Assay
SANTA CLARA, Calif., Nov. 6 /PRNewswire/ -- Affymetrix, Inc. (Nasdaq:AFFX) announced today the launch of its GeneChip(R) cytochrome P450 (CYP450) assay for research applications. The GeneChip CYP450 assay, developed in collaboration with Hewlett-Packard, is the first commercially-available DNA probe array based assay for the simultaneous detection of 18 known genetic variants (or polymorphisms) of two human cytochrome P450 genes (2D6 and 2C19). Enzymes encoded by these genes are critical for the research relating to the metabolism of certain important therapeutic drugs including beta blockers for cardiovascular disease, selected anticonvulsant medications and a large class of antidepressants.
The GeneChip CYP450 assay is designed to be more informative, faster and easier to use than current genotyping methods such as conventional dideoxy sequencing and restriction fragment length polymorphism analysis. The CYP450 assay will also provide genotype information on several alleles of P450 that are currently not routinely tested by traditional methods. The GeneChip CYP450 assay has demonstrated a greater than 99.7% base calling concordance with dideoxy sequencing for known variants of the 2D6 and 2C19 P450 genes. This product is the third commercially-available disease management assay using the company's proprietary GeneChip technology.
Raymond Woosley, M.D., Ph.D., of Georgetown University Medical Center, a leader in drug metabolism research and pharmacogenetics, has collaborated with the company on the development and testing of the GeneChip CYP450 assay.
''The GeneChip CYP450 assay is a powerful screening tool for these important variants of P450 genes,'' said Dr. Woosley, Chairman of the Department of Pharmacology and Co-Director of the cardiovascular institute at Georgetown University. ''By evaluating all of the known genetic variants of the 2D6 and 2C19 P450 genes, the CYP450 assay will enable us to more thoroughly understand the role of these genes in metabolism and help clinical investigators and eventually clinicians to stratify patients according to their genetic profile in order to maximize efficacy and minimize toxicity of many important classes of drugs.''
''The launch of the CYP450 assay marks Affymetrix' first commercial product that addresses the emerging field of pharmacogenetics, the correlation of drug efficacy and toxicity with polymorphisms or genetic variation,'' said Dr. Stephen P.A. Fodor, Affymetrix' President and Chief Executive Officer. ''We believe that this new approach may play an increasingly important role in drug research and eventually, clinical trials and disease management.''
The GeneChip CYP450 assay uses over 8,000 different oligonucleotide probe features synthesized on a glass ''chip'' to identify cytochrome P450 gene sequences encoding 15 known variations in the 2D6 gene and three known variations in the 2C19 gene. GeneChip software reports the presence of these known variations by analyzing the pattern of hybridization of DNA sample to these probes.
Affymetrix will market the GeneChip CYP450 assay to leading pharmaceutical and biotechnology companies, academic research centers and clinical reference laboratories for research use. The assay can potentially be used today in the development and post marketing process to help drug companies better understand patient responses to a given drug and develop more appropriate dosing regimens to reflect individual patient metabolic rates. |