FDA OKs 1st At-Home Genetic Tests for 10 Disorders

Francis Osborne
April 8, 2017

While the GHR tests may provide genetic risk information, they can not determine a person's overall risk for developing a disease, as other factors beyond genetics (ie, environment, lifestyle) may also influence risk. It is the first direct-to-consumer genetic test the FDA has allowed to provide that information.

The California-based company 23andMe gained approval from the Food and Drug Administration to market genetic testing for risk of 10 ailments, including Parkinson's and Alzheimer's diseases.

The newly approved tests will use saliva samples to report on telltale markers for conditions such as Coeliac disease, Gaucher disease type 1, and blood clotting disorders.

Thrombophilia (hereditary); a blood clot disorder.

But Shuren asked people to understand that mere genetic risk does not suggest a person will be developing a particular disease.

The FDA specifically excluded genetic tests that qualify as diagnostics, which are often used as the sole basis for treatment options.

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Genetic testing can be useful to find out certain disease and conditions you may be at risk of developing.

The FDA also announced they intend to create an exemption for subsequent GHRs from the company, which would allow similar tests from other manufacturers to market their own test kits after a one-time FDA review. An example would be a genetic test for a BRCA mutation that may lead to removal of a woman's breasts or ovaries in order to prevent cancer, the agency said.

The FDA said the authorization came after reviewing data from the company's tests and peer-reviewed literature that demonstrated the GHR tests "correctly and consistently identified variants associated with the 10 indicated conditions or diseases from a saliva sample".

The agency said it had established "special controls" to clarify its expectations of how well the tests should perform.

Users of these tests should consult a health care professional with questions or concerns about results, the FDA said.

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