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New DNA test: prescription for genetic precision.(Clinical Rounds)
Food and Drug Administration approval of the first DNA microarray test will allow physicians to consider patient-specific genetic information before prescribing medications for a variety of conditions such as cardiac disease, psychiatric disease, and cancer.
The new test offers comprehensive analysis of the cytochrome P450 2D6 (CYP2D6) and cytochrome P450 2C19 (CYP2C19) genes, and identifies the associated predictive phenotype (poor, intermediate, extensive, or ultra-rapid metabolizer). Variations can cause a patient to metabolize certain drugs more quickly or more slowly than average, or not at all.
"The use of this test should allow for more refined decision making in the deployment of a wide variety of drugs," Steven Gutman, M.D., director of the FDA's office of in vitro diagnostics, told this newspaper. "The psychiatric area is particularly rich with literature and with potential use. Those drugs are the stars of the show, but there are a wide variety of other drugs that may show similar impact.
Approval of the test "isn't the end of the story, but the first chapter in the journey toward personalized medicine," Dr. Gutman said. "People will be able to select drugs more carefully and in a way that meets the unique genetic, metabolic needs of the patient."
The AmpliChip Cytochrome P450 Genotyping Test made by Roche Molecular Systems Inc., Pleasanton, Calif., was approved for analysis of the CYP2D6 gene in late December and analysis of the CYP2C19 gene in early January. The test is available in Europe for analysis of both genes, at a cost of 400 euros. The cost for use of the test in the United States has not been determined, a Roche spokesperson said.
The test was cleared for use with the Affymetrix GeneChip Microarray Instrumentation System, manufactured by Affymetrix of Santa Clara, Calif.
A microarray is similar to a computer microchip, but instead of tiny circuits, the glass chip contains millions of DNA molecules. The DNA is extracted from a standard blood sample that must be sent to a ...
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