Thursday, December 5, 2013

23andMe grows up. Works to obtain 510k

23andMe has agreed to comply with the laws of the country in which they operate. Congratulations.

"At this time, we have suspended our health-related genetic tests to comply with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process. In the future, you may be able to receive health-related results, dependent upon FDA marketing authorization."

I remember speaking with Jim Woodman when he was at Pathway Genomics. We were discussing how fantastic it would be to work with physicians to develop a NGS testing service that would work seamlessly. I told him, that it is the best mass marketing they could do, because I felt their test was a medical device and that if they landed a big distribution deal, they could be subject to FDA scrutiny. He laughed and said, "We appreciate your point". 2 days later they announced the Walgreens Deal

In less than 24 hours, the FDA chimed in. I knew this simply and posted on this in 2009. Heck, everyone was pissed at me for saying this 5 years ago. SNP+ Interpretation is medicine.

I remember watching the first 23andMe ad on television. I was drinking a nice IPA. It nearly came out of my nose. I saw another one a day later. Then another. I said to myself, Oh My God! Google has bought the FDA.......

I was actually wrong. The FDA said, stop marketing your test. Then, I really followed this closely, as you can imagine. Some like Misha Angrist may say with some schadenfreude. But no, no. I am pained yet again. Companies keep making the same mistake. Arrogance, neglect for laws. Remember, this is the team, that I had to force to get an IRB and also had to force to use a CLIA approved lab.

They set back personalized medicine. Some fools climb the mountain without a Sherpa. This is what happens. For all those entrepreneurs who don't want this mistake. Email me

The Sherpa Says: I look forward to 23andMe's 510k application! The finally are growing up. Hope they don't bring back the blimp!