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AMA warns against DTC genetic testing

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Direct-to-consumer (DTC) genetic testing has the potential to undermine the relationship you have with your patients, according to the American Medical Association (AMA).

Direct-to-consumer (DTC) genetic testing has the potential to undermine the relationship you have with your patients, according to the American Medical Association (AMA).

In a letter to the Food and Drug Administration (FDA) last week, the AMA asked the regulatory body to ensure that DTC genetic testing is done only under the supervision of qualified health professionals. An FDA panel is scheduled to hold hearings on the tests 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,” Ardis D. Hoven, MD, AMA chair, said in a press 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.”

In addition to regulation of DTC genetic tests, the AMA supports the creation of a Genetic Testing Registry that would include information about the clinical authenticity of each test available.

Last year, the FDA sent letters to 5 companies that provide genetic testing services, warning them that the kits they sell are considered medical devices and subject to the agency’s approval.

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