Anne Wojcicki thought she might be able to get the FDA off by her back if 23andMe stopped advertising its $99 genetic testing kits. But when your company is five years late on "analytical and clinical" studies that prove your product does what it promises and ignored the agency's questions for five months, they're not inclined to shrug it off.
In a blog post yesterday, Wojcicki said she was "highly disappointed," but 23andMe will comply with the FDA's directive and halt its services while it submits to regulatory review:
Our goal is to work cooperatively with the F.D.A. 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 validity of the science is also being disputed in a class action lawsuit.
Earlier this week, Wojcicki, who is separated from Google cofounder Sergey Brin, her husband and investor, acknowledged that 23andMe played a role in prompting the FDA's actions. Well, sort of:
The problem, Anne Wojcicki said on Tuesday, is that the F.D.A.'s approval system is set up to approve individual tests, but 23andMe tests about a million components of a person's DNA. Filing for a million approvals would be impossible, she said. [...]
"We completely recognize we're behind schedule; we failed to communicate proactively," she said.
The FDA's warning letter to Wojcicki in November paints a different picture:
In [Wojcicki's] letter dated January 9, 2013, you stated that the firm is "completing the additional analytical and clinical validations for the tests that have been submitted" and is "planning extensive labeling studies that will take several months to complete."
The warning letter also expressed concern that 23andMe's results might prompt consumers to take inappropriate actions, like surgery or chemoprevention, "while a false negative could result in a failure to recognize an actual risk that may exist." Supporters argued that people should be able to access information from their own DNA (the FDA explicitly stated that it has no problem with that) and that it was "borderline absurd" to think that someone would get a mastectomy based on a $99 test.
However, Wojcicki hasn't shied away from alluding to that sort of outcome in the press, telling Fast Company:
"Angelina Jolie talking about a technical subject and saying, 'I did this, you can do this' is a great thing for us," says Wojcicki. "She did something to prevent disease, and that's exactly what we want people thinking about."
According to the New York Times, the review process will be months or longer. But in the same post where she agreed to the FDA's directive, Wojcicki touted all the personal data 23andMe has been able to collect and will continue to work with:
Research is and will continue to be a significant priority for the company. The 500,000+ customers we have today have given us more than 250 million survey data points. You, our customer, have powered an incredibly important crowd-sourced research database that I believe can have a significant impact on the pace of discoveries and cures. We will continue our Parkinson's, sarcoma, MPN and African American research projects and plan to launch more communities in 2014.
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[Image via Makers]