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 the 23andMe 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, almost everyone's hand was raised. And genetic testing isn't limited to 23andMe. They have competitors (who must be quite concerned as well).

23andme had dropped its price this year to go to mass market. At $99 a test, 400 000 users had signed up. This growth may well have contributed to the FDA's timing...They couldn't wait any longer with that number of users.

The FDA warning letter is here. It's not news to 23andMe, because the FDA had begun to raise red flags in 2009, two years after the company's launch. The FDA said, "you are a device. Please act like one." Who knows why they didn't heed the warning? Was it impossible to maintain a going business and undertake the investment? Was it lack of experience with the regulatory side of healthcare? Was it some form of internal miscommunication?

I believe that if 23andMe had been managed with strong input from managers with drug and device backgrounds, the business would have taken the FDA requests very seriously and not moved forward in the same way.. I would imagine that there would have been investors to follow them on that solid if slower path.

The story will surely unfold over the coming weeks...