Wellness

FDA Approves At-Home Alzheimer’s Testing Kit

23andme Gets FDA Approval to Test

* 23andme is now approved to test for Alzheimer’s, Parkinson’s and Celiac
*The company waited three years for approval
*It’s the first genetic health risk test available without a prescription

Genetic testing company 23andme was approved by the FDA on Thursday to test consumers on their predisposition for ten different diseases. After a three-year-long battle, the Mountain View-based company is now allowed to market its direct-to-consumer product, which will test predispositions for Parkinson’s, Alzheimer’s, and Celiac, among others. The FDA has specified that although the tests will provide genetic risk information, it cannot determine an individuals overall total risk.

The Alphabet Inc.-backed company initially started with selling their kits to help people investigate ancestry, as well as offering up data to drug companies to assist with development. With this FDA approval, the company now becomes the first to sell genetic health risk reports without a prescription. Although granting its approval, the FDA is careful to state that there are also “additional environmental and lifestyle factors” that contribute to the development of a health condition.

The kits work by using your saliva samples to test over 500,000 genetic variants, and using their presence or absence to determine the likelihood of certain conditions. As the device cannot actually diagnose disease, the FDA reviewed it under the novel, “low-to-moderate-risk” device pathway, and will not require any additional review before it goes to market.

CEO and co-founder of 23andme, Anne Wojcicki (photo above), stated that the FDA has “embraced innovation and empowered individuals by authorizing direct access to this information.”

The new testing kits are scheduled to launch later this month.

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