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(c) 2016 Jon L Gelman, All Rights Reserved.

Friday, December 6, 2013

Genetic Tester to Stop Providing Data on Health Risks

Genetic testing of employees has been a concern of legislators over the last decade. Just when, one thinks the problem is contained, technology and the Internet emerge with new and critical issues. Do-it-yourself genetic testing creates new issues even more challenging than before. Today's post was shared by The New York Times and comes from www.nytimes.com


Bowing to the Food and Drug Administration, the genetic testing service 23andMe said Thursday that it would stop providing consumers with health information while its test undergoes regulatory review.
The decision was in response to a warning letter sent by the agency two weeks ago saying that the genetic test was a medical device that requires approval.
“We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives,” Anne Wojcicki, the chief executive of 23andMe, said in a statement Thursday evening.
“Our goal is to work cooperatively with the F.D.A. to provide that opportunity in a way that clearly demonstrates the benefit to people and the validity of the science that underlies the test.”
The company will continue to take orders for new tests but will provide only ancestry information and raw data, without interpretations of the health implications. It said it might resume providing health data if it receives regulatory approval.
23andMe sought approval of certain of its tests in 2012 but did not provide information the F.D.A. required. After the company began advertising on television, the agency ordered it to stop marketing its test.
The company then halted advertising, apparently hoping that it could stop “marketing” but continue selling. But it appears that regulators did not buy that...
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