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17 April 2014 12:48 pm ,
Vol. 344 ,
Officials last week revealed that the U.S. contribution to ITER could cost $3.9 billion by 2034—roughly four times the...
An experimental hepatitis B drug that looked safe in animal trials tragically killed five of 15 patients in 1993. Now,...
Using the two high-quality genomes that exist for Neandertals and Denisovans, researchers find clues to gene activity...
A new report from the Intergovernmental Panel on Climate Change (IPCC) concludes that humanity has done little to slow...
Astronomers have discovered an Earth-sized planet in the habitable zone of a red dwarf—a star cooler than the sun—500...
Three years ago, Jennifer Francis of Rutgers University proposed that a warming Arctic was altering the behavior of the...
- 17 April 2014 12:48 pm , Vol. 344 , #6181
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DNA Testing Company Won't Offer Health Information Anymore
6 December 2013 1:45 pm
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."