At-home genetic test for 10 diseases gets first FDA approval

At-home genetic test for 10 diseases gets first FDA approval

At-home genetic test for 10 diseases gets first FDA approval

The screening services are the first direct-to-consumer tests authorized by the FDA that provide information on an individual's genetic predisposition to certain medical diseases or conditions.

Included in the list are Alpha-1 antitrypsin deficiency, a disorder that raises the risk of lung and liver disease, Factor XI deficiency, a blood clotting disorder, Gaucher disease type 1, an organ and tissue disorder, early-onset primary dystonia, a movement disorder, and various blood disorders.

The test kits are able to isolate DNA from saliva samples to test for more than 500,000 genetic variants that could increase risk for certain diseases.

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".

"But, it is important that people understand that genetic risk is just one piece of the bigger puzzle".

Thrombophilia (hereditary); a blood clot disorder. The special controls will also act as a benchmark for other companies developing similar tests.

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The FDA said it does not plan exemptions for genetic health risk tests that function as diagnostic tests, which might be used for major treatment decisions.

While US laws like those enforced by the Genetic Information Nondiscrimination Act of 2008 are meant to prevent genetic screens from being interpreted as an existing conditions by insurance companies and used to deny coverage, it's also hard to say how effective the act has been, and will be in the future.

FDA cautions that test results carry risks of false findings, and consumers with questions or concerns about a finding should consult with a healthcare professional.

Purchasing an Ancestry and Health kit from 23andMe will enable customers to automatically test for eight of the diseases; Parkinson's and Alzheimer's disease will require customers to specifically ask for those tests to be added.

The U.S. National Human Genome Research Institute has more on genetic testing.

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