Genetic Testing Company to Stop Providing Data on Health Risks

genetic-testing-halted-by-fdaThe genetic testing service 23andMe, under pressure from the U.S. Food and Drug Administration (FDA), has agreed to discontinue providing information on health risks while the test undergoes regulatory review.

The decision came in response to a warning letter the FDA sent to the company two weeks ago, alerting 23andMe that it considered the genetic test a medical device that requires FDA approval, The New York Times reports. Anne Wojcicki, 23andMe’s chief executive, said the company remains committed to its “mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives.”  She added that the company would work cooperatively with the FDA.

It is estimated that about half a million people have used the company’s genetic testing service, which costs $99. A DNA analysis is performed on a saliva sample submitted by the purchaser. Until the change in policy, test results have included information about how high or low the person’s risk for certain diseases, and how the individual might react to certain medicines, according to the Times. The test is offered directly to consumers, not through doctors or genetic counselors, which is one of the FDA’s concerns.

In the warning letter, the FDA expressed concern that consumers might take inappropriate actions based on the test results. But supporters of the company and such directly available testing say these concerns are unfounded and that individuals have the right to information contained in their own DNA.

Until the matter is resolved, the company will provide only ancestry information and raw data to test takers, without interpreting health risks. If 23andMe receives FDA approval, it could resume providing health data, the Times reports.


This entry was posted in Health Concerns. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.