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.
On June 4-5, DeviceTalks Minnesota is taking over the Twin Cities medtech industry with one of the most anticipated conferences of the spring.
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