The American Medical Association is expressing its concerns to the U.S. Food and Drug Administration regarding the “unfettered growth” of direct-to-consumer genetic testing.
Regulate consumer genetic testing: AMA
In a letter Wednesday to the FDA, AMA officials said the marketers of such tests often make dubious scientific claims. The AMA also said direct-to-consumer testing has the potential to undermine the physician-patient relationship.
In the letter, the AMA addressed the Molecular and Clinical Genetics Panel of the FDA's Medical Devices Advisory Committee and urged them to ramp up regulations and oversight to ensure that genetic testing is carried out under the supervision of a qualified health professional.
“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 Dr. Ardis Hoven, chair of the AMA board of trustees, in a news release. “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.”
Of particular worry are the direct-to-consumer genetic tests—such as those that indicate the risk for developing certain types of cancer—that could lead patients to pursue potentially inappropriate medical interventions or therapies, the AMA said in the letter.
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