AMA to FDA: Genetic Testing Should Be Conducted by Qualified Health Professionals
For immediate release:
Feb. 23, 2011
WASHINGTON – In a letter to the Food and Drug Administration (FDA), the American Medical Association (AMA) today called for genetic testing to be conducted under the guidance of a physician, genetic counselor, or other genetics specialist. The letter was sent to the Molecular and Clinical Genetics Panel of the FDA's Medical Devices Advisory Committee regarding direct to consumer genetic tests prior to the panel’s hearings on the topic, scheduled for March 8 and 9.
“Without the benefit of proper medical counseling, patients may spend money on direct to consumer genetic tests needlessly or misinterpret the results of the tests, causing them to make unnecessary or unhealthy lifestyle changes,” said AMA Chair Ardis D. Hoven, MD. “While genetic testing can be a valuable tool to aid in diagnostic and therapeutic decisions, it should be done under the guidance of a physician, genetic counselor, or other genetics specialist. These health professionals are best prepared to help patients understand the results and the limitations of the tests, and what type of action should occur based on the results.”
The AMA supports regulation of direct to consumer genetic tests, as well as the creation of a Genetic Testing Registry (GTR), which should include information about the clinical authenticity for each test available to patients. With an increasing number of tests available, this type of information would allow physicians to communicate with their patients about the capabilities and limitations of these tests.
Heather Lasher Todd