23andMe, a DNA testing company that came to symbolise Silicon Valley’s ambition of grabbing a leading position in the emerging world of personalised medicine, was ordered on Monday to stop selling its testing kits after a long-running dispute with federal regulators.
The Food and Drug Administration said it had taken the action because imprecise results from the tests could mislead customers into pursuing unnecessary medical treatments or failing to get vital medical help.
Founded by Anne Wojcicki, the wife of Google founder Sergey Brin and younger sister of top Google advertising executive Susan Wojcicki, 23andMe has marketed its DNA testing kits for the past five years. It has raised more than $160m from high-profile backers in the tech world, including Google Ventures.
However, the difficulty of providing data detailed enough to give customers significant new insights into their odds of contracting diseases, along with growing pressure from regulators, has weighed on the business.
“The market has fallen way short of what the enthusiasts expected a few years ago,” said John Conley, a law professor at the University of North Carolina and editor of Genomics Law Report. 23andMe has about 400,000 customers, but has begun television adverts to expand its business – one reason the FDA gave for acting now to stop its sales.
The agency first put a chill on the market for personal gene testing in 2010, when it wrote to companies that offered consumer services, including 23andMe, questioning whether they needed to seek formal approval for selling their products under regulations aimed at the medical devices.
Ms Wojcicki’s company was the only one to have continued actively pursuing a consumer market, Mr Conley said, maintaining that people had a right to the information about their DNA make-up.
In a letter to the company, the FDA said some intended uses of its test kit were “particularly concerning”, such as testing for the BRCA mutations that cause breast and ovarian cancer. A false positive could lead to treatments such as a mastectomy, while “a false negative could result in a failure to recognise an actual risk that may exist”, the agency said.
In a statement, 23andMe said it was “committed to fully engaging with [the FDA] to address their concerns”.
Mr Brin revealed in 2008 that he had used information generated during one of the company’s tests to find a genetic mutation that made him more susceptible to contracting Parkinson’s disease, though 23andMe’s own analysis of the data had not identified the condition.
“Until the fountain of youth is discovered, all of us will have some conditions in our old age only we don’t know what they will be,” Mr Brin wrote at the time. “I have a better guess than almost anyone else for what ills may be mine – and I have decades to prepare for it.”
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