[paula_w]

..and other DNA analysis firms.

http://www.mercurynews.com/business/...nclick_check=1

Here come the regs to slow down another study.

[olsen]

The primary reason my husband was a participant in the DNA profiling offerred by 23andme was the fact the foundation was attempting to conduct their own research--without the structure of sanctioned medical research and FDA involvement. He admired their chutzpah and initiative (not to mention their cash reserves), attempting to answer the questions they had without waiting for someone in medical research to get around to these questions.

[pkell]

It seems rediculous for the FDA to take such a stand. All 12andnme is doing is collecting data they are not inventing treatments or prescribing actions. There are dozens of DNA collecting companies that do the same thing for the sake of tracing ones ancestry. I guess they'll go after them next.

[olsen]

Another issue to tackle? I am writing to the FDA to voice my outrage over potential interference with 23andme's function.

[LindaH]

It goes beyond the FDA . Congress is also involved now-- the issue is now being examined by the House Comm. on Energy and Commerce. Time to educate ourselves on the issue and make sure the perspectives of patients are heard.

excerpt below from Modern Medicine "FDA sends letters to Illumina and genomics suspected of selling unapproved products" june 23, 2010


http://www.modernmedicine.com/modern...tegoryId=40159

"FDA’s action prompted the U.S. Congress to open an investigation into DTC genomics providers. The House Committee on Energy and Commerce sent letters to three firms — Pathway Genomics, 23andMe, and Navigenics — requesting information on several aspects of the tests they sell directly to consumers, including the specific diseases and drugs for which the services provide genomic risk data; policy documents and materials on genetic counseling or physician consultation; data showing the accuracy of the risk predictions delivered by these services; details on policies regarding handling of DNA samples; and documents relating to the services’ compliance with FDA regulation.

FDA has yet to set any formal guidelines specific to DTC genomics firms, but it has always said it has the authority to regulate these services. "

[violet green]

Thank you Linda, for reminding us that we need to make our voices heard on this. Hope we can prevail and not have it slowed down by regulatory agencies of any type.

katherine