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FDA Approves First Direct-to-Consumer Genetic Tests

FDA Approves First Direct-to-Consumer Genetic Tests

A Personal Genome Service Genetic Health Risk test can detect a person’s genetic predisposition to 10 conditions.

On April 6, the Food and Drug Administration (FDA) authorized 23andMe, a genetic testing service, to release Personal Genome Service Genetic Health Risk (GHR) tests. It's the first time the FDA has approved a direct-to-consumer test for genetic predisposition to different conditions.

Here’s how it works: After submitting a saliva sample, a person’s DNA will be tested for 500,000 genetic variants. The presence or absence of certain variations may be linked to an elevated risk of developing 10 specific conditions, including:

  • Parkinson’s disease, a progressive disorder of the nervous system that affects movement
  • Late-onset Alzheimer’s disease, a brain disorder that causes problem with memory, thinking and behavior
  • Celiac disease, an immune reaction to the protein gluten

The test provides information, but that's just a fraction of the larger picture. Detection of a certain genetic variant doesn't automatically mean you'll develop the condition—many factors, including a person’s environment and lifestyle, also contribute.

Among the requirements placed on 23andMe by the FDA is the use of consumer-friendly language in GHR test instructions and reports. A readability study of the materials suggested users understood more than 90 percent of the information.

The tests are not perfect, and risks of false positives do exist. Results of the GHR test should not be used for diagnosis, and users should consult their healthcare provider for any questions and concerns regarding their test results.  

Image credit: 23andMe

Medically reviewed in August 2018.

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