You can finally get an FDA-approved genetic test for diseases from 23andMe

Emma Hinchliffe
Updated

23andMe is already telling curious customers everywhere they're descended from, but the genetics service has finally received permission to provide a little more information based on DNA samples. 

23andMe now has approval from the Food and Drug Administration to tell its users if they're at a higher risk of some diseases based on their DNA. 

That's what the startup tried to do originally, before it was forced to shut down that service since it didn't have FDA approval to provide actual medical knowledge based on its genetic testing. Now, the service is allowed to tell users if they're at risk for 10 diseases: 

  • Parkinson’s disease

  • Late-onset Alzheimer’s disease

  • Celiac disease

  • Alpha-1 antitrypsin deficiency, a disorder that raises the risk of lung and liver disease;

  • Early-onset primary dystonia, a movement disorder involving involuntary muscle contractions and other uncontrolled movements

  • Factor XI deficiency, a blood clotting disorder

  • Gaucher disease type 1, an organ and tissue disorder

  • Glucose-6-Phosphate Dehydrogenase deficiency, also known as G6PD, a red blood cell condition

  • Hereditary hemochromatosis, an iron overload disorder

  • Hereditary thrombophilia, a blood clot disorder

The FDA noted in its announcement that this is the first approved use of direct-to-consumer tests for genetic risks. The information provided by 23andMe won't involve actual diagnoses of diseases — only the genetic risk of having them. 

As Vox pointed out, before 23andMe hit some major stumbling blocks with its medical plans in 2013, the startup wanted to provide information about a lot more than 10 diseases. At one point, 23andMe planned to determine risks for 254 health conditions.

As of late, 23andMe has provided some basic health information to its customers, but only in categories that aren't subject to the same kind of regulation: lactose intolerance, genetic weight and alcohol flush reaction, among others. 

Now the FDA is open to some uses of direct-to-consumer besides heritage breakdowns. Although 23andMe can still do that. 

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