23andMe drops health claims due to FDA letter

Posted Dec 6, 2013

23andMe has announced that they will comply with the Food and Drug Administration’s demand to stop marketing health-related genetic tests. 23andMe is known for selling $99 personal genome tests. People that are still interested in a DNA test can still pay 23andMe to learn about their ancestors. But 23andMe will not be able to warn people about having genetic profiles, which predisposes them to certain illnesses.

“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, co-founder and CEO of 23andMe, said in a statement. “Our goal is to work cooperatively with the FDA 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 FDA sent a warning letter to 23andMe in late November saying that they failed to provide answers to many questions that were raised in 2012. The FDA also criticized 23andMe for failing to finish and start certain cases that was brought up as long as five years ago that were necessary to make a decision about the marketability of the company’s personal genome services.