FDA approves 23andMe’s genetic testing kit

FDA approves 23andMe’s genetic testing kit

The U.S. Food & Drug Administration (FDA) has finally approved 23andMe’s personal genetic test for certain diseases, including Parkinson’s, Alzheimer’s, and celiac diseases.

The FDA said in statement that the genetic test assess genetic risk for the aforementioned conditions but does not diagnose them. The federal agency also urged people to use their results to help make decisions regarding lifestyle choices and to inform discussions with a healthcare expert.

Jeffrey Shuren, the director of the federal agency’s Center for Devices & Radiological Health, said, “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 list of other known factors which can play a role in the development of disease includes diet, environment and use of tobacco products.

FDA officials cautioned that genetic risk is merely a piece of information and it doesn’t mean an individual will sooner or later get the disease.

Currently, 23andMe’s personal genetic health risk test costs $199.


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