On its website"the company quotes numbers for risk from published scientific papers,but you'd have to be pretty sophisticated to know that if the study was done on western Europeans it might not be relevant to you if you're Chinese,"said geneticist Dr Jeff Murray of the University of Iowa and president of the American Society of Human Genetics (ASHG).
The FDA said in its letter that 23andMe had submitted applications in July and September of 2012 for several uses of its saliva test but had failed to address issues raised by the agency or to provide additional information requested. As a result,the FDA said,the applications"are considered withdrawn."
The company said its relationship with the FDA is"extremely important to us and we are committed to fully engaging with them to address their concerns."
Dr David Agus,a professor of medicine and engineering at the University of Southern California and founder of Navigenics,one of the first personal-DNA testing companies,said the FDA's letter to"is not a death knell to personal DNA testing"but should be a wake-up call."We have to be transparent with consumers about what sequencing their genome can and cannot reveal,"he added.
Navigenics was acquired last year by Life Technologies Corp.
The FDA said it had been"diligently working"to help 23andMe comply with the law,and spent significant time evaluating the intended uses of the DNA-testing product. It said it provided detailed feedback to the company through more than 14 face-to-face and teleconference meetings,hundreds of email exchanges,and dozens of written communications.
"However,even after these many interactions with 23andMe,we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses,"the FDA said.
While 23andMe may not have been communicating with the FDA,Ms Wojcicki has been talking at length to the media. Earlier this month she told the New York Times that her company had mapped the genotypes of 475,000 people over the last five years and expected to"hit a million"in the first quarter of 2014.
In a recent article in Fast Company,Ms Wojcicki said her ultimate goal was to sign up 25 million people."Once you get 25 million people,there's just a huge power of what types of discoveries you can make,"she said.
The company name refers to the 23 pairs of chromosomes that make up each individual's genome.
After years of trying to obtain from 23andMe the information it needs to ensure the tests are accurate,the FDA appears to have finally lost patience.
"I think this will certainly grab the attention of a lot of other companies out there,"said Joseph McInerney,executive vice president of the ASHG.
Reuters