23andMe Steps Back

The company announces that it will stop offering health interpretations of personal genetic data.

By Abby Olena | December 6, 2013

WIKIMEDIA, JEROME WALKERLast month in an open letter, the US Food and Drug Administration instructed genetics company 23andMe to stop marketing its Personal Genome Service (PGS) due to lack of communication from the firm and because the agency was “concerned about the public health consequences of inaccurate results.” PGS customers paid $99, sent in a saliva sample, and received individual ancestry and genetic information, as well as an interpretation of their genetic data related to 254 health conditions. 23andMe announced yesterday (December 5) that it would no longer provide health interpretations for new customers, but that it would continue to provide raw genetic data and ancestry information as it works with the FDA to conform to regulations.

In a statement, 23andMe explained that PGS customers who purchased or received the results of their kits before November 22, 2013 will still have access to health-related results. Customers who purchased their kits after this date are eligible for a refund or may opt to receive raw genetic data and ancestry information only. “These new customers may receive additional health-related results in the future, dependent upon FDA marketing authorization,” the statement said.

“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,” 23andMe cofounder and CEO Anne Wojcicki said in the 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 also seems to be on board. “We agree that access to tests through a direct-to-consumer model will allow consumers to take a more active role in certain aspects of their health,” Commissioner Margaret Hamburg wrote in a letter to The Wall Street Journal on December 3. “We remain committed to continuing our ongoing dialogue with the company in order to bring a safe, effective and trusted product to the market.”

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Avatar of: CSfromSC


Posts: 3

December 9, 2013

Big Pharma is likely influencing the FDA decision.  They don't want to begin drug testing based on phenotypes because of the expense.  Information in the hands of consumers is not in their interest.  Drug companies would no longer be able to dismiss problems with pharmaceuticals as inconsequential when testing shows that most or all of individuals with a particular genetic profile are harmed by a drug which is well tolerated by others.


Avatar of: wctopp


Posts: 110

December 9, 2013

The large shareholders of 23andme are probably looking hard at who in top management needs to be remaindered.

Avatar of: Tra1666


Posts: 1

December 9, 2013

The FDA is not being driven by Big Pharma.  Give them a break.  They have a stated policy not to block innovation which 23andme is trying to provide.  They also have an obligation to uphold the law and if you have read anything you would know that after 14 face to face meetings with the FDA 23andme refused to stop marketing their bogus testing providing dangerous faulty un-scientific speculative interpretations of data they had no right to provide.

Truth be told, I wonder why the Agency took so long to take these idiots down.  23and me is just another example of Silicon Valley know-nothing mogels who never created anything requiring consistent quality WORK whining about how hard it is to really make money in a Real industry like Pharma. 

Go back to creating games for 13 year olds, or spying on innocent users Google (23andme founded with money from do-nothing Google founder wife-- as if that's a surprise).

Avatar of: Bug


Posts: 1

December 12, 2013

It's neither a "Big Pharma conspiracy" nor an ignorant money-grubbing Silicon Valley company. If you take the time to examine the 23andMe website, you will see that for all results they link to original papers and sources. Customers can examine the science behind their genetics. This does, however, require an educated consumer (or one willing and able to educate themselves). Fortunately there are numerous groups that users can join to exchange information and ask questions. As best I can tell, 23andMe makes no unsubstantiated or unscientific claims AND takes pains to ensure that customers who don't understand their results (or their significance) have several avenues to better understand the science. That is commendable. While I do believe the FDA is largely a force for good, and I believe 23andMe is a responsible company, I am not clear on exactly what the issues are between the FDA and 23andMe. I have not yet found a source that explicitly details those differences; eveything (including the article above) is vague on those key points.

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