23andMe wins FDA approval to give customers health risk info

The gene testing company can now tell US customers who use its home DNA kit whether they have a genetic risk for any of 10 diseases and conditions.

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Gene testing company 23andMe can now tell customers whether they have a genetic risk for any of 10 diseases, including Parkinson's disease, celiac disease and late-onset Alzheimer's disease.

The US Food and Drug Administration said on Thursday that 23andMe could market its genetic health risk tests for several diseases and conditions, making it the first home DNA test authorized by the regulator.

This is a big win for 23andMe, which stopped giving health analysis information to US customers in 2013 after being reprimanded by the FDA. The Google-backed startup continued to sell its home DNA kits but provided only ancestry information in the US. In 2015, the FDA gave the company its approval to tell US customers their "carrier status" -- meaning whether they could pass a gene mutation on to children -- for 36 hereditary diseases.

"This is an important moment for people who want to know their genetic health risks and be more proactive about their health," Anne Wojcicki, 23andMe's CEO and co-founder, said in a release."It is a significant step forward for 23andMe and for the adoption of personal genetics."

The FDA cautioned, however, that genetic predisposition shouldn't be confused with a diagnosis.

"Consumers can now have direct access to certain genetic risk information," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a release. "But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won't ultimately develop a disease."

23andMe can now provide genetic risk information on:

  • Parkinson's disease
  • Late-onset Alzheimer's disease
  • Celiac disease
  • Alpha-1 antitrypsin deficiency
  • Early-onset primary dystonia
  • Factor XI deficiency
  • Gaucher disease type 1
  • Glucose-6-Phosphate Dehydrogenase deficiency
  • Hereditary hemochromatosis
  • Hereditary thrombophilia