Has the FDA dealt a lethal blow to 23andMe?

I'm based in Europe, and so it was the afternoon today, when the news of the FDA warning letter to 23andMe surfaced. The FDA have asked the company to stop selling the23andMe Saliva Collection Kit and Personal Genome Service (PGS),which is basically the only product of the company.One year ago, I had the great fortune to be the panel moderator at Medicine X, (Stanford Medicine, Palo Alto). Medicine X is a partner conference to Doctors 2.0& You.Anne Wojcicki the brilliant and charismatic co-founder of 23andMe described her company's genetic testing service and why she had created it.Here's the video.  Two reasons for consumers to use 23andMe, according to their CEO: consumers own their data and once they know their results, they can take preventive actions. Everyone must act instead of remaining unknowingly at risk for the inefficacy or intolerance of certain drugs, or at risk for certain diseases. 23andme had tested Sergei Brin, the Google co-founder and then spouse of the 23andMe cofounder and found that he had a high risk for Parkinson's disease.What can a patient do with the information? This is a different story, and that is where the PGS becomes a device, in FDA terms, a device that is not authorized to be one. Yet, in listening to the video, it sounds like 23andMe makes action recommendations based on  the test results.When I asked the Silicon Valley audience for a show of hands on how many people had done a genetic test, almo...
Source: Denise Silber's eHealth - Category: Information Technology Authors: Tags: Doctors 2.0 eHealth Quantified Self Source Type: blogs