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First Genetic Disease Screening Kit For Consumers Gets FDA Approval

23andMe, the genetic testing service co-founded by Anne Wojcicki, has won landmark approval to administer tests for risk of developing 10 hereditary illnesses. In a new ruling, the Food and Drug Administration reversed its 2013 decision to deny the company approval.

Included among the conditions it screens are Parkinson’s Disease, Alzheimer’s Disease, celiac disease and Gaucher Disease –- a rare ailment suffered mostly by Ashkenazi Jews, which results in bone and joint pain, spleen issues and potential neurological damage.

23andMe offers a package in which consumers provide a DNA sample to the company and for $199 get a report breaking down their ethnic ancestry and risk for a host of diseases.

Vox notes that this makes it “the first company to sell regulator-approved genetic predisposition tests directly to consumers.”

FDA officials, while approving the company’s plans, warned that genetic testing is not the final word on whether a person will develop a given illness. “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,” Jeffrey Shuren, head of the agency’s Center for Devices and Radiological Health, wrote in a statement.

Contact Daniel J. Solomon at or on Twitter @DanielJSolomon




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