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FDA approves first DTC genetic tests for disease risks.

The Food and Drug Administration has authorized the marketing of 23andMe's Personal

Genome Service Genetic Health Risk (GHR) tests, the first direct-to-consumer genetic screening tests to become available. FDA officials expect the product, which tests individuals for possible genetic predisposition for 10 diseases including Parkinson's disease and late-onset Alzheimer's disease, to spur patients to consult with their physicians and make more informed lifestyle decisions.

"These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual's genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional," according to the FDA press release announcing the decision.

The other diseases covered by the tests are celiac disease, alpha-1 antitrypsin deficiency, early onset primary dystonia, Factor XI deficiency, Gaucher disease type 1, glucose-6-Phosphate Dehydrogenase deficiency (also known as G6PD), hereditary hemochromatosis, and hereditary thrombophilia.

The GHR test works by testing DNA from an individual's saliva for more than 500,000 genetic variants. FDA officials warn that, while the test gives users a better idea of the odds of one of these diseases manifesting, it is not meant to be used as a diagnostic tool.

"Consumers can now have direct access to certain genetic risk information," said Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health in the release. "But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won't ultimately develop a disease."

The FDA's decision was supported by data from studies that included those that showed a link "between specific genetic variants and each of the 10 health conditions."

In addition, a study of the tests' instructions and reports found that those using the tests "understood more than 90 percent of the information presented in the reports," according to the FDA statement.

Risks of the tests include false-positive and false-negative results, and "results obtained from the tests should not be used for diagnosis or to inform treatment decisions," the statement added.

The FDA is advising consumers to consult a health care professional with questions or concerns about results.


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Author:Zimmerman, Eli
Publication:Dermatology News
Date:May 1, 2017
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