FDA Clears Test of Patient DNA To Screen for Drug Effectiveness
Associated Press
December 24, 2004; Page A9
WASHINGTON -- The Food and Drug Administration said it approved a test that will allow doctors to check a patient's DNA when choosing certain medications.
The FDA called it the first laboratory test system for doctors to use in reviewing patients' genetic information. It is meant to improve doctors' ability to prescribe medications for conditions such as cancer and heart and psychiatric diseases. The agency said the specific enzyme analyzed by this test plays a key role in the body's ability to metabolize some commonly prescribed drugs including antidepressants, antipsychotics, beta-blockers and some chemotherapy drugs.
The new test is the first DNA microarray test to be cleared by the FDA and paves the way for similar microarray-based diagnostic tests to be developed.
"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 acting FDA commissioner Lester M. Crawford.
The new test is the AmpliChip Cytochrome P450 Genotyping Test made by Roche Molecular Systems Inc., Pleasanton, Calif. The FDA said the test was cleared for use with the Affymetrix GeneChip Microarray Instrumentation System, manufactured by Affymetrix Inc., Santa Clara, Calif.
The test uses DNA from a patient's blood. It analyzes one of the genes from a group called cytochrome P450 genes, which are active in the liver to break down certain drugs and other compounds.
Variations in this gene can cause a patient to metabolize certain drugs more quickly or more slowly than average, or, in some cases, not at all, the FDA said.
online.wsj.com |
