FDA fears inaccurate test results could harm consumers.
23andMe, the personal genomics company, has been ordered by the Food and Drug Administration to halt the marketing of its $99 genetic testing service.
In a letter sent on Friday, the FDA chided the company for dragging its feet in complying with federal regulations. The agency notes that it has been working with the company since July 2009 to help it comply with applicable rules. It recounts 14 meetings, hundreds of emails, and dozens of written communications.
Despite this long history of interaction, the FDA says 23andMe has not provided any assurance that its personal genomics test has been validated analytically or clinically for its stated purpose.
Because of absent documentation that the tests provide accurate genetic data, the FDA fears test flaws could lead to unnecessary medical procedures or customers failing to take advisable medical actions.
"For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist," the FDA's letter states.
23andMe acknowledged receipt of the FDA's letter and said it intends to satisfy the agency. "We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission," a company spokesperson said in an emailed statement. "Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."
The company did not immediately respond to a request to clarify whether it will fulfill orders that have been paid for but not yet processed, or whether it will delay fulfillment until the FDA's concerns have been met.
23andMe's regulatory shortcomings demonstrate yet again that the web advertising business model exemplified by Facebook and Google -- launch company, amass data, make a profit -- doesn't translate well to the rules-heavy healthcare industry.
For Google cofounder Sergey Brin, one of the company's financial backers -- and the recently separated spouse of 23andMe CEO Anne Wojcicki -- this lesson might evoke a sense of deja vu: Google launched a health service of its own back in 2008, only to shut it down in 2011 for lack of interest. Nonetheless, Google is back at it; it introduced a health services company called Calico in September.
In December 2012, Wojcicki announced an effort to sell a million of 23andMe's personal genomics tests by the end of this year, backed by $50 million in new funding. Three months earlier, she reported that the company had about 180,000 customer profiles in its database.
It appears the company will fall short of its goal. In September 2013, BusinessWeek reported that 23andMe had reached 400,000 customer profiles.
Over the summer, 23andMe hired a new executive, Andy Page, a board member and former president of luxury shopping company Gilt Groupe, to assist its effort to attract more customers.
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