Summary
The US Food and Drug Administration (FDA) has approved the first at-home genetic test that can help to determine a person’s risk of developing certain diseases.
Today’s long-awaited action allows the consumer-genetics firm 23andMe to market a test for 10 genetic conditions, including Alzheimer’s and Parkinson’s diseases, to consumers — and paves the way for a wave of do-it-yourself diagnostic tests. The company says that it will begin offering the new service in the coming months.
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Hank Greely, a bioethicist at Stanford University in California, worries that consumers might not understand the limits of the test results without help from a genetic counsellor or a physician — particularly as 23andMe expands the medical conditions that it covers, and other companies begin to offer similar services. “I’m not a big fan of cutting out the middleman when the middleman is a trained professional and most of the country doesn’t understand much about health,” Greely says.
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“This shows that working with the FDA can be a route forward,” Greely says. “Silicon Valley has a neurosis about the FDA and regulation, and that is not helpful — particularly in healthcare, where lives are at stake.”
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