These At-Home DNA Tests Are Now FDA-Approved

First Consumer Genetic Health Risk Test Gets FDA Approval

The Food and Drug Administration has approved for marketing the first direct-to-consumer genetic profile tests that consumers can use to learn if they have a genetic predisposition to any of 10 particular medical diseases or conditions.

Besides Parkinson's or late-onset Alzheimer's disease, they include: celiac disease; alpha-1 antitrypsin deficiency, which increases risk of lung and liver disease; a movement disorder called early onset primary dystonia; factor XI deficiency (hemophilia C), a blood clotting disorder; and Gaucher disease type 1, which causes liver and spleen enlargement and growth retardation.

The tests are easy to use and isolate DNA from a saliva sample, which can be sent away to be tested for more than 500,000 genetic variants thought to be related to these diseases. In 2013, the agency told 23andMe to stop selling its personal genome kits in the United States until they gained FDA approval by proving they were accurate.

The 10 conditions are all heavily determined by DNA variants - and the company has demonstrated the ability to relay the risk factors in consumer-friendly ways that have been backed by peer-reviewed science, the federal agency announced. In addition, this may nudge them to make key changes in their lifestyle choices to minimize the incidence of these diseases.

The FDA has previously scolded the company for marketing the personal genetic testing kits without the agency's consent. After mailing in their sample, people can see their results online.

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The FDA tempered its announcement with the warning that genetic risk does not "mean [people] will or won't ultimately develop a disease".

While some have welcomed the FDA approval, others are wary of direct-to-consumer genetic testing.

Freivogel said speaking with a genetic counselor before getting tested for disease is important.

If there was a way to know that you were genetically at risk for Parkinson's Disease would you want to know?

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