In a harshly worded letter, this U.S. Food and Drug Administration (FDA) this week ordered genetic testing company 23andMe to halt marketing of its home DNA kits until it received FDA approval. The genetic testing kit allows people to send in a sample of their saliva to be tested for inherited conditions, health risks and drug responses, as well as to identify their genetic ancestors.
The FDA's letter alleges that 23andMe's "device" is in violation of the Federal Food, Drug and Cosmetic Act because "it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease." Among the FDA's specific complaints are phrases from 23andMe's marketing materials that promise that their tests are a "first step in prevention" and allow users to "take steps toward mitigating serious disease." The FDA and 23andMe have apparently been in negotiations over these claims for more than a year, with the agency asked the company to back up its claims on dozens of occasions. The discussions, however, appear to have ceased; the FDA letter says the agency has not heard from the company since May, during which time 23andMe has started advertising its products on television.
In response to the FDA's letter, 23andMe released a short statement: "We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."
The $99 genetic testing kits are, as of this writing, still available for purchase on 23andMe's website. The company is also still actively marketing the product online, as I encountered while writing the story. After Googling the company name, the following ad appeared in my Facebook feed:
23andMe, launched in 2006, has received more than $126 million in venture capital from several companies, including Google, as well as from Google co-founder Sergey Brin. Brin is married to 23andMe CEO and co-founder Anne Wojcicki. (The couple have separated.) Earlier this year Wojcicki told Fast Company that her goal is have 1 million customers by the end of 2013, and 25 million people after that. She said the value for the company is not individual customers but the collective database of their genetics.
"Once you get 25 million people, there's just a huge power of what types of discoveries you can make," she told the magazine. "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?" Board member Patrick Chung said that data could then be sold to pharmaceutical companies, hospitals and government agencies.
To find out more about how 23andMe works, watch the video below:
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