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FDA issues personal genomic sequencing firm strong warning

Plummeting DNA sequencing costs are making personal genome sequencing a reality. However, interpreting raw sequencing data is not trivial. For the last five years, 23andMe has been offering interpretations of the sequencing data for its customers, called "Personal Genomic Services", which could be used to help make health-related decisions. But the company has failed to acquire the necessary approval to provide such medically guided information, which has culminated in a more serious warning by the FDA. "23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device," stated the letter.

"The problem is that 23andMe is marketing health information directly to consumers without any medical intervention. Without that conduit, if you don't have the right background, you don't have the necessary concepts to understand what's being given to you," said Theresa Scocca, trained human geneticist and regulatory scientist.

23andMe is not the only company that offers personal genomic sequencing and interpreted results. Back in 2008, a science reporter for Discovery described her consumer experience with 23andMe and two other companies, Navigenics and deCODE genetics, highlighting the complex and nuanced nature of interpreting health outcomes based on sequencing results. "Some of the test results from the three companies matched up with one another. Some didn't," she wrote.

Scocca stressed a similar sentiment: "Nothing about this or any of the information they give you is a yes or no answer. Additionally, you may not have an allele that makes you more prone [to some condition], but that doesn't mean you're not prone at all—that can be a very dangerous conclusion."

While several companies were scrutinized and warned by the FDA back in 2010 for such (medically contentious) health-related interpretations, 23andMe's aggressive marketing strategy seems to have exacerbated an already difficult regulatory situation.

"The FDA likely became more and more concerned about what exactly they were marketing and how much medical influence that might have on people. The FDA letter was uniquely specific towards 23andMe and its product. Its wording was very direct and pointed," said Scocca.

It appears that this has finally spurred 23andMe into action, as the company has suspended offering health-related interpretations along with the raw sequencing data (which is still available). "Our goal is to work cooperatively with the FDA...in a way that clearly demonstrates the benefit to people and the validity of the science that underlies the test," said Anne Wojcicki, 23andMe's CEO, in a press release.