FDA approves personal genome test

"Consumers can now have direct access to certain genetic risk information", said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health.

The 10 diseases that consumers will be able to test for include Parkinson's disease, late-onset Alzheimer's, celiac disease, alpha-1 antitrypsin deficiency, early-onset primary dystonia, factor XI deficiency, Gaucher disease type 1, glucose-6-phosphate dehydrogenase deficiency, hereditary hemochromatosis, and hereditary thrombophilia. In addition, the FDA looked at studies which showed that 23andMe GHR tests correctly and consistently identified variants associated with these conditions from saliva samples.

The tests will help individuals know their genetic vulnerability to various diseases including Parkinson's and Alzheimer's.


Somehealth professionals worry that consumers will "take the results and run", as Mary Freivogel put it. Freivogel, a certified genetic counselor and the president of the National Society of Genetic Counselors, added that genetics are just "one piece to the story when it comes to developing a disease".

Genetic testing can be useful to find out certain disease and conditions you may be at risk of developing.

The newly approved tests work by isolating DNA from a saliva sample.


Genetic variants will not lead to the development of a health condition as environmental and lifestyle factors also influence the eruption of a disease.

The FDA, which in 2013 blocked the company from providing genetic health information, announced its decision Thursday. While approving consumer use, FDA did establish criteria for expectations in tests' accuracy, reliability and clinical relevance. It is a significant step forward for 23andMe and for the adoption of personal genetics, " Wojcicki said in the company's statement. The decision is expected to open the floodgates for more direct-to-consumer tests for disease risks, drawing a road map for other companies to do the same thing. The tests will be marketed as part of the US$199 Health and Ancestry test that the company already provides.



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