Posted: December 6, 2013
While the company tries to work things out with regulators, it won't be telling people who buy its test if their genetic profiles predispose them to particular illnesses or predict their responses to prescription drugs.
The maker of a $99 personal genome test blinked.
Silicon Valley's 23andMe said late Thursday that it would comply with the Food and Drug Administration's demand that the company stop marketing health-related genetic tests.
People will still be able to pay 23andMe to have their DNA analyzed to learn about their ancestors. And customers will get a file of their raw genetic info.
But while 23andMe tries to work things out with the FDA, the company won't be telling people they have genetic profiles that predispose them to particular illnesses, or predict their responses to prescription drugs. In other words, no more health claims.
"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 company has a pretty deep regulatory hole to crawl out of.
The changes in 23andMe's marketing come in the wake of a scathing warning letter the agency sent in late November. The agency said then that it hadn't heard from the company since May and that 23andMe had failed to provide answers to a bunch of questions raised in 2012.
FDA also faulted 23andMe for failing to finish, and in some cases even start, studies discussed as long as five years ago that the agency said would be necessary to make a decision about the marketability of the company's personal genome services.
Advocates cried foul, saying the agency's heavy-handed letter would stifle the development of personalized genomic information before it gets off the ground.
In a letter to The Wall Street Journal this week, FDA Commissioner Margaret Hamburg defended the agency's approach:
"The FDA appreciates that many consumers would like to be informed about their genomes and their genetic risk for developing certain diseases. 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."
"The agency's desire to review these particular tests is solely to ensure that they are safe, do what they claim to do and that the results are communicated in a way that a consumer can understand. Without FDA review, any safety concerns are unknown and could potentially lead to patient harm, such as a consumer receiving a false positive or negative result that leads to an unnecessary treatment or delays care."
There may be a workaround.
On 23andMe's Facebook page, Susan Price Davis asked the company for clarification of its new approach:
"I am confused... You say no health related results will be returned, but you say all raw data will be returned. So, we get the health related results, just not the interpretation?"
The company replied:
"You get the raw data about your genotype with no interpretation from 23andMe. That's correct."
And with the raw data in hand, motivated consumers will still be able to run health analyses using tools available online.
Erin Martijn, another commenter on the Facebook thread, pointed people to Promethease, which uses a catalog of genetic variations to prepare a personalized genome report. "It's not as pretty as 23andMe's health report charts but it works!" she said.
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