FDA Allows 23andMe To Sell Genetic Tests For Disease Risk

The FDA has approved 23andMe Inc's direct-to-consumer genetic test for personal disease risks, according to The Wall Street Journal.

"Consumers can now have direct access to certain genetic risk information", said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. But it cautioned that genetic risk is just one piece of information and does not mean they will or won't eventually get a disease.

The 10 conditions are all heavily determined by DNA variants - and the company has demonstrated the ability to relay the risk factors in consumer-friendly ways that have been backed by peer-reviewed science, the federal agency announced.

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The 10 conditions are alpha-1 antitrypsin deficiency, Parkinson's disease, celiac disease, factor xi deficiency, late-onset Alzheimer's disease, glucose-6-phosphate dehydrogenase deficiency, Gaucher disease type 1, hereditary hemochromatosis, hereditary thrombophilia, and early-onset primary dystonia. The FDA said it also had crafted streamlined procedures to make it easier for other makers to develop and submit similar tests for approval. In addition, this may nudge them to make key changes in their lifestyle choices to minimize the incidence of these diseases.

The U.S. FDA has expressed the intention to allow for a mechanism for exempting subsequent GHRs from the genetic testing company. Additional research confirms this information can be identified from a saliva sample.

Sharon Terry, the CEO of the Genetic Alliance, a nonprofit organization that advocates for health care for people with genetic disorders, likens it to another consumer test. "Women learn they are pregnant using a test directly marketed to them and buy it off the shelf in a drugstore", she told NPR. Often, patients were required to see a genetic counselor before getting a test.

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If there was a way to know that you were genetically at risk for Parkinson's Disease would you want to know?

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