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The Food and Drug Administration approved the first home DNA tests Thursday that let people find out if they have a genetic risk for certain diseases.
The FDA decision allows home DNA test company 23andMe to directly market its gene tests for 10 diseases, including Parkinson’s, Alzheimer’s and some rare blood diseases.
“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,” the FDA said in a statement.
“Consumers can now have direct access to certain genetic risk information,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, which approves these kinds of tests.
“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.