The U.S. Food and Drug Administration (FDA) has approved the marketing of the first laboratory test system that will allow physicians to consider unique genetic information from patients in selecting medications and doses of medications for a wide variety of common conditions such as cardiac disease, psychiatric disease, and cancer.
“Physicians can use the genetic information from this test to prevent harmful drug interactions and to assure drugs are used optimally, which in some cases will enable patients to avoid less effective or potentially harmful treatment choices,” said Dr. Lester M. Crawford, Acting FDA Commissioner.
The new test is the AmpliChip Cytochrome P450 Genotyping Test made by Roche Molecular Systems, Inc., of Pleasanton, Calif. It was cleared for use with the Affymetrix GeneChip Microarray Instrumentation System, manufactured by Affymetrix, Inc., of Santa Clara, Calif.
The new test is the first DNA microarray test to be cleared by the FDA and its clearance paves the way for similar microarray-based diagnostic tests to be developed in the future. A microarray is similar to a computer microchip, but instead of tiny circuits, the chip contains millions of tiny DNA molecules. The test is performed using DNA that is extracted from a patient's blood. A person's DNA sequence is determined based on the sequence of the probe molecule to which the DNA is most similar.