For the first time, the Food and Drug Administration said it would allow a company to sell genetic tests for disease risk directly to consumers, providing people with information about the likelihood that they could develop various conditions, including Parkinson’s and Alzheimer’s.
The move on [April 6] is a turnaround for the agency, which had imposed a moratorium in 2013 on disease tests sold by the company, 23andMe, which is based in Mountain View, Calif. 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.
23andMe will now be reporting telltale markers for 10 diseases. Most, like factor XI deficiency, a blood clotting disorder, and Gaucher disease type 1, an organ and tissue illness, and celiac disease are rare.
Until now, the only way for people to get such genetic tests was to see a medical professional who would order a test and later deliver the results to patients. Often, patients were required to see a genetic counselor before getting a test.
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