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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 ...
Source: Gene Sherpas: Personalized Medicine and You - December 6, 2013 Category: Geneticists and Genetics Commentators Source Type: blogs

23andMe received the FDA CRL. Response letter. Cease and Desist to follow?
Like I said. They Blew Off LawsIgnored Age Old Research Protocols, like an IRBI was made fun of.....They Played nice with the FDAThen Blew Them OffAdvertised on TVAnd 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 (Source: Gene Sherpas: Personalized Medicine and You)
Source: Gene Sherpas: Personalized Medicine and You - November 26, 2013 Category: Geneticists and Genetics Commentators Source Type: blogs

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 live...
Source: Gene Sherpas: Personalized Medicine and You - October 20, 2013 Category: Geneticists and Genetics Commentators Source Type: blogs

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 sa...
Source: Gene Sherpas: Personalized Medicine and You - February 20, 2013 Category: Geneticists and Genetics Commentators Source Type: blogs

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 said1. 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 databaseIf 99 dollars isn't giving it away, I have no clue what is2. 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 hea...
Source: Gene Sherpas: Personalized Medicine and You - December 31, 2012 Category: Geneticists and Genetics Commentators Source Type: blogs