23andMe Founder Vows To Cooperate With FDA, Addresses Customer Concerns

Customers who purchased kits as of November 22 can receive a refund as the genetic testing startup works its way out of FDA limbo.

This evening, Anne Wojcicki, CEO and founder of Google-backed genetic testing company 23andMe vowed to cooperate with the FDA, which ordered the company stop marketing its $99 DNA testing kit on Nov. 25. Wojcicki expressed regret but also stood behind the company's mission.

Anne Wojcicki

"I am highly disappointed that we have reached this point and will work hard to make sure consumers have direct access to health information in the near future. Our goal is to work cooperatively with the FDA to provide that opportunity," she wrote in a post on the company's website. "We also want to make clear that we stand behind the data we have generated for customers."

She also addressed the number of 23andMe customers caught in a kind of limbo: Either they'd purchased the kits and had yet to mail in a saliva sample for results about various genetic traits and risk factors; or they'd purchased the kit, mailed in the saliva sample and were awaiting results. In a blog post on the company's website, Wojcicki offered the following:

  • Customers who purchased kits on or after the FDA’s warning letter of November 22nd will not have access to health-related results. Those customers will have access to ancestry-related genetic information and their raw data without 23andMe’s interpretation of that data. They may receive health-related results in the future, depending on FDA marketing authorization.
  • Customers who purchased kits before November 22, 2013 will continue to have access to all the reports they’ve always had.
  • We are offering customers who purchased kits as of November 22, 2013 a full refund if they wish. Those customers will get an email from 23andMe with details on the refund policy. Eligible customers who do not receive an email are encouraged to check their spam email folders for the email with their personalized instructions or contact our Customer Care Team.

Last week the Food and Drug Administration ordered that 23andMe stop marketing its genetic testing kids to consumers or face fines. Earlier this week, the company did stop. Despite very real philosophical differences between the two organizations, the schism occurred because of a communications break down, as Fast Company reported this morning.

DNA-testing kitImage: Flickr user Pelle Sten

Before this seemingly abrupt set back, 23andMe founder Anne Wojcicki said in our November cover story she wanted to sign up 25 million people for her $99 test by the end of 2013. "Big data is going to make us all healthier. What kind of diet should certain people be on? Are there things people are doing that make them really high-risk for cancer? There's a whole group of people who are 100-plus and have no disease. Why?"

Empowering people with their genetic knowledge, in theory, can help them take health care into their own hands, argued Wojcicki. "The great loophole in all of health care is that you own your own data and ultimately you can direct your care. We’re direct to consumer not because it’s easy, but because that’s how you create a revolution," she said at Fast Company's Innovation Uncensored event.

The FDA, however, felt that the inaccuracies of the tests, which can lead to false positives, hindered this goal, misleading people to take unnecessary and sometimes drastic medical procedures. For example, the 23andMe results might incorrectly turn up a BRCA gene mutation, which indicates a high propensity for breast cancer. That, in turn, might lead someone to get a preventative mastectomy—a pretty invasive procedure—based on faulty results.

Following the FDA announcement, Wojcicki insisted 23andMe's tests provide "quality" information. "It is absolutely critical that our consumers get high quality genetic data that they can trust," she wrote in a post on the company site. "We have worked extensively with our lab partner to make sure that the results we return are accurate. We stand behind the data that we return to customers — but we recognize that the FDA needs to be convinced of the quality of our data as well."

As of November 23andMe had sent out half a million kits, and Wojcicki wrote Thursday evening that it had collected 250 million survey data points.

[Image: Flickr user Col Ford and Natasha de Vere]

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