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.

2013 what predictions? Eh Sherpa

Ok. I just put this here because I like Andrew Dice Clay. Here's my take. Let's look at what happened in 2012 and my predictions.
Here's what I said

1. In regards to DTC Genetics, the FDA won't shut you down if you are google.But you will have to give your test away for free to build your database

If 99 dollars isn't giving it away, I have no clue what is

2. In regards to Pharmacogenomic testing, most doctors won't use the service despite studies showing utility that have existed for 2 years.

They still didn't in 2012.
3. In regards to GWAS predisposition testing, it is mostly useless. It doesn't scare or heal you.......most of the time

Nothing has changed science wise with this statement

So Now, after months off I have to come up with brilliance. Really?
Navigenics=Dead DecodeMe=Dead Pathway=Weight Loss genetics 23andMe=Giving tests away next to free

DTC Genomics is not the play here. 

For personalized medicine to succeed, the clinicians still need to learn and the students need to teach.

Prediction 1. A true 1000 USD genome will come out in 2013, late November, early December

Prediction 2. Someone will sue 23andMe for privacy violations

Prediction 3. A big set of PGx data will be released....and ignored.

Prediction 4. Hillary Clinton will have either cancer or a stroke. Her health reports are suspect at best.

Prediction 5. Nutrigenomics will begin to have much more press coverage.

The Sherpa Says: I am here, blocking and tackling. Awaiting the next phase of the climb. 

5 years later, Navigenics fulfills my prophecy

From August 24 2007 (5 years ago)

Just wanted to give a shout out to David Hamilton from Venture Beat who wrote about Navigenics a while ago. To me whether 23andMe has a competitor or not does not matter. All that it sounds like is another non-clinical company trying to be clinical..........

From his article

"In other words, Navigenics essentially intends to get people to have their genomes scanned in a rough-and-ready fashion — in other words, they’ll scan your genes with chips that look for single-letter variations in the genetic code, instead of laboriously reading it out letter by letter — and then to match up what they find with the latest information on the diseases to which your genes might predispose you. Navigenics so far seems focused on the question of what your genes might say about disease, whereas 23andMe is apparently also interested in helping people trace their genealogy and creating social networks where they can compare and contrast their genetics."

And my favorite quote: "At the very least, though, it’s clear Navigenics has come loaded for bear. In addition to the blue-chip VC backing......"

The thing my mother always taught me.......the more money you need to market and sell something, the more likely it is that people don't need it........


Thoughts????? 

It appears, my thoughts were correct.....

 From August 2012 HT D.C.

Dear Navigenics Member,

Navigenics was recently acquired by Life Technologies. As the Navigenics team transitions its focus to Life Technologies’ developing molecular diagnostic business, we want to thank you for your patronage and making genetics a part of your health.

This email will be the final communication from Navigenics. Here are some important things to know about your Navigenics account:

• Your genetic information is yours. Your genetic results will be available to you in your secure online account for three years, and you may log in to the Navigenics portal as usual to access your genetic information: https://www.navigenics.com/member/login. Please bookmark the link to your account for future reference. After August 2015, to ensure the privacy and security of your information, your genetic results will be deleted and will no longer be available to you online. Any remaining genetic samples you may have stored with us will have already been destroyed and discarded.
• Your privacy is our priority. In compliance with its existing policies and informed consent, Navigenics will not sell or share customers’ personally identifiable or genetic data.

You can find additional information in our online FAQs: https://www.navigenics.com/visitor/about_us/acquisition_faqs/.

Wishing you the best of health,

Navigenics Member Service

Navigenics Member Service can be reached directly at 1-866-522-1585 ormemberservice@navigenics.com. If you do have questions or need to contact us for any reason, please do so before September 21, 2012. After that time Navigenics Member Service will no longer be available by email or phone.

4 Embarcadero Center, Suite 1400. San Francisco CA, 94111

member.service@navigenics.com

1-866-522-1585

The Sherpa Says: No matter how much money you spend in SoHo, you shoulda made sure you could test the people in NYC.

23andMe proves the Sherpa right and kisses the ring!

In case you have been wondering where the Sherpa has been. Have a read.

I have been following the DTCG and FDA closely and it appears, my theory and logic is correct!


23andSerge has decided to stop being silly and stop fighting "The Man" Instead they kiss the ring and FINALLY acknowledge what I have said over and over again. If you are testing for medical conditions, if you are doing medical tests, you must be regulated as such.


Despite this, Anne W and 23andSerge fought for years. "It's research" "It's for fun" "It's not medical"
Further, 23andSerge's move proves the "brilliant" Thomas Goetz dead wrong and me, the little "ol Sherpa, spot on correct.


23andSerge will be asking for FDA approval of their medical device known as the 23andMe test.


Why does a service like this need FDA oversight? Because it is a medical device. Simple enough. Also, oversight is needed for this service as they cannot be trusted to police themselves.


Further, with inaccurate information, the FDA will have a very close look at what 23andSerge is offering.


IMHO, this move by 23andSerge is exactly what is needed to prove to all the skeptics wrong. 23andMe is doing medical testing and needs to be regulated as such. END OF STORY.


The Sherpa Says: I hate to say I told you so. But, I did. Just like I warned the guys at Pathway not to launch DTC via a major retailer. They did 2 weeks later and then got shut down.