FDA Grants 23andMe Authorization for Genetic Risk Tests for 10 Diseases

Helix DNA 6

Helix DNA 6

It is the first direct-to-consumer genetic test the FDA has allowed to provide that information.

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 use DNA from a saliva sample and test for more than 500,000 genetic variants.

The approval - granted to the California-based company 23andMe Inc. - could help test users make lifestyle choices or spark important discussions with health care providers, the FDA said.

The tests assess genetic risk for the conditions but don't diagnose them, the FDA says.

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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". "It's not like there's a drug you can take right now [to prevent the disease] or a lifestyle change you can make that you shouldn't make anyway", such as exercising and eating right to keep your brain healthy. The tests can not be used to actually diagnose disease.

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.

To use the genetic test service of 23andMe, a person only has to spit into a tube and send it to the company where the lab will work on extracting DNA from the saliva cells and look for genetic markers using a special chip.

Consumers should be aware that false positives and false negatives are possible with these tests.

But some are stillconcerned about whether the genes in question actually correspond to a higher risk of disease reliably enough to warrant direct-to-consumer marketing and testing, as opposed to genetic testing with the guidance of a professional.