23andMe is back: FDA allows marketing of genetic health risk tests

[Image courtesy of 23andMe]

FDA this month allowed genetic testing company 23andMe to market genetic health risk tests for 10 diseases and conditions including Parkinson’s disease and late-onset Alzheimer’s disease.

The de novo premarket review authorization, announced April 6, also included celiac disease, which results in the inability to digest gluten; alpha-1 antitrypsin deficiency, which raises the risk of lung and liver disease; early-onset primary dystonia, a movement disorder; factor XI deficiency, a blood clotting disorder; Gaucher disease type 1, a disorder involving organs and tissue; glucose-6-phosphate dehydrogenase deficiency, also known as G6PD, a red blood cell condition; hereditary hemochromatosis, an iron overload disorder; and hereditary thrombophilia, a blood clot disorder.

In providing the authorization to 23andMe, FDA also set up a new one-time review process to allow genetic testing companies to get their products to consumers as quickly as possible. 23andMe, for example, won’t need to seek authorizations for additional tests to add to its $199 health and ancestry service, now that it has received the first authorization.

Get the full story on our sister site, Medical Design & Outsourcing.

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