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 thegenesherpa@gmail.com

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

23andMe received the FDA CRL. Response letter. Cease and Desist to follow?

Like I said. 
They Blew Off Laws
Ignored Age Old Research Protocols, like an IRB
I was made fun of.....
They Played nice with the FDA
Then Blew Them Off
Advertised on TV

And really expected to get away Scott Free??? Really??? Fire Anne Woj......

FDA says, no way! Stop Selling, just like they did with Pathway and Walgreens.....



The Sherpa Says: Don't play games with the FDA

23andMe GATTACA children Patents, Google Master Race

(Sergey and Anne, divorced now)

I have not posted in forever. Before I used to post on novel efforts for Personalized Medicine I thought would be promising. Some of those are coming closer, like CardioDX or HCV genotypic treatment.


I also would post on things I thought would stall and distract us. One of the biggest culprits to this in my humble opinion was the model of Direct to Consumer testing that offered medical test results. 

Why did I opine on this? Why was I so concerned? In 2007 I stared at Linda Avey and I saw the total lack of concern to duty for the noble calling. I also saw a lack of concern for patient lives. 23andMe repeatedly have incorrect testing results, their desire to use a database for genomic patents, their desire to end around research ethics by first doing research without an IRB. This information prompted me to write a scathing warning in Nature Biotechnology in May of 2009. "In need of a reality Check" serves as a reminder that mega-lord Tech companies are dedicated to profit, not to the hippocratic oath. Not that I begrudge them for that. I just feel my country should contemplate what a company should be doing in the human care and healthcare space.

When asked what is the duty of a DTC company to offer follow up or change of a variant of uncertain significance or interpretation. Joanna Mountain looked at Linda Avey, Linda nodded and Joanna said "We don't have a duty to follow up!"

I was incredulous and countered this assertion. I said, as a physician when I do genetic testing, I have a duty to follow up. Dietrich Stephan from Navigenics said "We have a subscription model which will do this"

Navigenics is now dead. Why? They weren't funded by Google. Let me tell you something about the company that is now 1000 USD per share. They are dedicated to bringing the future. This is valuable.

What is scary? The future they are bringing is THEIR future. The companies they fund, like 23andMe and their CEO "Forbes' most daring" to bring about what they THINK we all should be doing and thinking and gobbledeegook of a terms of service states these things!

As a business it is brilliant. As an ethical company to grow mankind.....well, not so much IMHO.

Now the evidence I missed. 23andMe a Google funded company has applied for Patents that cover creating a master race according to parent specifications via preimplantation genetic diagnosis. Not rare, fatal diseases. Rather, eye color, hair color, height. How can they do this? You have given up your genetic privacy! Even Venture Beat mentions is. Heck, I wonder how many Genomes were given up to the NSA via PRISM.

I didn't believe it when I read it  but then I went and did a patent search. It is indeed correct. US Patent No. 8543339

So when you are spammed with the heavy amount of tweeting ads that @23andme is pumping out or the ads on FoxNews (Rupert Murdoch investor?) and other channels, think about what my warning. When hoping that Google or 23andMe will keep their customers safe and healthy, don't hold your breath. While physicians have taken an oath to first do no harm, Technology companies nor the "Internet" have taken no such oath!

The Sherpa Says: Do we want an America that grants 23andMe patents for creating Master Races? Really? 

Coriell Spinoff Allows Biobanking of Patient Genomes!

Has anyone seen this cool idea? Coriell Institute is spinning off a very cool idea. 

Coriell and IBM will be collaborating to store patient genomes for cloud based analysis. 

While it is certain to face detractors due to security concerns and perhaps competing systems.......

 “I am a bit concerned if we really start to outsource data to the cloud without any regulation,” says Emiliano De Cristofaro, a cryptography scientist with Xerox’s PARC who is developing a genomic data storage and sharing platform. “We must not forget that the sensitivity of genomic information is quite unprecedented,” he says"......It is highly likely to succeed. 

While I agree security is paramount......you really can't go wrong with IBM. Seriously. I am certain, given Coriell's stance on their research collaborative (Full disclosure, I sit on both the ICOB and PAG boards) which is utmost science and peer review, that they will also be just as scrupulous with this new spin off company!

This of course had all been in the works for months now, as it was telegraphed in November of last year ON IBM's blog SmartPlanet

The Sherpa Says: This cloud based storage and analysis is the future. Given the security challenges, you must have an excellent IT partner. Coriell has chosen wisely as will succeed with this venture.