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FDA Clears Some Drug Reaction Genetic Tests, Warns About Others

DNAmolcule model

(Skeeze, Pixabay)

1 Nov. 2018. The Food and Drug Administration cleared a consumer genetics company’s tests for gene variations associated with effective or adverse drug reactions, but warned about similar tests from non-authorized providers. The agency yesterday gave the go-ahead to 23andMe in Mountain View, California to market tests directly to consumers in the U.S. for genetic markers associated with drug metabolism, but today issued a separate warning expressing concerns about similar tests from providers that are not cleared by FDA.

Pharmacogenetics testing reveals genetic variations that are shown to affect the metabolism of drug compounds in the body. The tests can indicate if a drug may be effective and an appropriate dose of the drug. Likewise, the tests can show if a person may have a serious adverse reaction to the drug. The results can be helpful, in consultation with physicians, in determining treatment strategies for patients, and in the case of adverse effects indicate potential life-threatening drug reactions.

The company 23andMe conducts on-demand genetics testing for individuals to determine their ancestry and genetic traits, or reveal inherited health risks. Customers of these services are given the option to take part in research studies, usually involving surveys, that connect genetic factors and variations with medical conditions. According to the company, more than 80 percent of 23andMe’s 5 million customers agree to take part in these studies.

FDA yesterday authorized 23andMe to market its tests for drug reactions to consumers. The agency cleared 23andMe’s tests that detect for 33 genetic variations associated with metabolizing more than 50 drug compounds sold over the counter or by prescription, according to 23andMe. The company says it provided data documenting the accuracy of its tests, as well as consumer comprehension of the results, including guidance on changing or stopping the drug. Among the results cited by 23andMe are findings that show 97 percent of test users understand they should not use test results to change or stop taking a drug without consulting their doctors.

The agency’s statement yesterday points out that the authorized tests only identify genetic variations and do not predict outcomes of specific drugs in specific individuals. Test results should also be confirmed by independent assessments before making any medical decisions. In addition, FDA issued special controls on the tests, including label notices that users should not use the results to stop or change their use of medications.

Today, directors of FDA Center for Devices and Radiological Health and Center for Drug Evaluation and Research — Jeffrey Shuren and Janet Woodcock respectively — issued a statement warning consumers against pharmacogenetics tests from unauthorized providers. Shuren and Woodcock specifically pointed out concerns with “genetic tests being marketed directly to consumers or offered through health care providers that claim to predict how a patient will respond to specific medications.” They added, “Tests that make such claims that have not been evaluated by the FDA and are not supported by prescribing recommendations in the FDA-approved drug label, may not be supported by scientific and clinical evidence, and may not be accurate.”

Shuren and Woodcock cite genetic tests used by some physicians to predict effectiveness or side effects of some antidepressant drugs, as well as compared to similar drugs. They note that some health care providers also make changes in a patient’s drug regimens based on solely genetic tests, which could harm the patient. The agency added that the authorization yesterday for genetic tests by 23andMe “was granted with limited indications and is subject to special controls.”

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