The FDA Has Huge News For At-Home Genetic Tests

Photo: Getty Images.
At-home genetics tests are about to get a lot more specific than just reporting where your ancestors are from. The New York Times reports that the FDA will allow 23andMe to sell genetic tests that can tell customers the likelihood of developing diseases like Parkinson's and Alzheimer's.
Previously, 23andMe was not allowed to market itself as a disease test. In 2013, the FDA put a stop to that, but the company continued to provide tests that offered up insights to ancestry and other information. The new regulation will allow 23andMe (and, presumably, a slew of other companies) to test for markers associated with 10 different diseases, including "factor XI deficiency, a blood clotting disorder; Gaucher disease type 1, an organ and tissue illness; and celiac disease."
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"The difference between then and now is that we now have authorization to tell you about your personal risk," Anne Wojcicki, chief executive at 23andMe, told The New York Times.
For $199, customers will get information on the aforementioned diseases, as well as Alzheimer’s and Parkinson’s. For that information, customers will need to go through an additional consent process to ensure they're informed about the information they're about to receive. There's no additional fee for Alzheimer’s and Parkinson’s information, but 23andMe will offer contact information for local psychological counseling in case anyone has questions about their results. This is similar to the process before at-home tests. Patients could request genetic testing from their doctors and often, those doctors would recommend some counseling before and after the test. 23andMe recommends genetic counseling or a physicians visit for anyone who has a family history of disease or just wants to learn more about their results.
The new test will include all the information from 23andMe's previous package, which includes ancestry as well as data on how much a person is likely to weigh, how flushed they will become from alcohol consumption, and more.
Doctors say that the results could be dangerous for some patients. "Once you get the test and read the results, there is no going back," Dr. James Beck, chief scientific officer of the Parkinson's Foundation, told the Times. He recommends genetic counseling before getting a test, noting that there is a possibility for distress when considering the test and when getting results.
The 23andMe disease test may be new to the States, but it has been available in both Canada and the U.K. since 2014. 23andMe says that after over 20,000 tests in Britain, there have been no incidents in regards to disease risk results.
"Hopefully, this information will be delivered in a way that has value to the person purchasing the service and does not cause unneeded medical visits," Dr. Gail P. Jarvik, head of the division of medical genetics at the University of Washington, told the Times via email. "Many of these tests indicate risk of getting disease, not the certainty of getting it."
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