The company 23andMe will no longer provide health information to people who purchase its DNA testing kit, it announced last night.The change was "to comply with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process," the statement said. While current customers will still have access to a 23andMe online database noting the health issues associated with their particular DNA, the company will not update that information, and customers who purchased its Personal Genome Service (PGS) on or after 22 November will receive only information about their ancestry and their raw genetic data without interpretation.
The move comes after a 22 November letter by the U.S. Food and Drug Administration (FDA) warned the Mountain View, California-based company to "immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device." The regulatory agency expressed a variety of concerns, including that patients might change dosage of medications or even abandon therapies because of 23andMe test results on drug responses.
The FDA action has sparked a vigorous debate over the rights of people to learn their own genetic information and the authority of governments to regulate marketing claims related to health. 23andMe says on its website that its services are “for research, informational, and educational use only. We do not provide medical advice." But the company has emphasized the medical uses of its test in recent marketing, says Cecile Janssens, an epidemiologist at Emory University in Atlanta who has studied the accuracy of risk predictions made by 23andMe and other companies. "It used to be more about what science knows about your DNA," she says. "But in the past year they really went on a different track. It is more about health recommendations now."
Just days after the FDA letter, a lawsuit was also filed against 23andMe in a U.S. district court in California alleging that test results provided by the company were "meaningless."