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View Poll Results: To what degree should the FDA (or similar) regulate consumer genetic testing?
None, DNA wants to be free 9 60.00%
Moderate, there is a middle ground 4 26.67%
High, testing only through physicians 2 13.33%
Voters: 15. You may not vote on this poll

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Old 11-23-2007, 04:47 PM   #1
ECO
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Location: SF Bay Area, CA, USA

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Default Genetic Freedom: How soon until the FDA shackles 23andMe/deCODEme?

GenomeWeb has a short writeup today that questions the FDA’s regulatory intentions for consumer genetic testing. The article includes some statements from the founders of the new personalized genomics companies deCODEme and 23andMe regarding their attempts at staying “aligned with all of the objectives and the principles of [these regulatory agencies]”.

The GenomeWeb editor summarizes their quotes in a hilarious sentence: “Officials from Decode […] and 23andMe […], stressed that they are not offering consumers genetic tests…”. In my opinion this intentional “toss our hands up and claim ignorance” policy is exactly what will get these companies in hot water. Any company whose main business model involves genotyping 1 million loci and offering risk calculations should be a champion of genetic freedom causes, not making the farcical argument that they are not offering genetic tests. I would expect both companies to have a clearly thought out path for driving policy change in this arena, with a specific stance on personal ownership of genetic information. Otherwise our rights to information contained within our own cells are clearly in danger (not to mention their business plans...).

It is clear, from a statement released by the ACMG years ago (see text below and complete statement in attachments to this post), that they feel they are the gatekeepers of genetic information and will lobby for regulation of 23andMe and deCODEme (emphasis mine):

Quote:
Genetic tests of individuals or families for the presence of or susceptibility to disease are medical tests. At the present time, genetic testing should be provided to the public only through the services of an appropriately qualified health care professional. The health care professional should be responsible for both ordering and interpreting the genetic tests, as well as for pretest and posttest counseling of individuals and families regarding the medical significance of test results and the need, if any, for follow-up. Due to the complexities of genetic testing and counseling, the self-ordering of genetic tests by patients over the telephone or the Internet, and their use of genetic “home testing” kits, is potentially harmful. Potential harms include inappropriate test utilization, misinterpretation of test results, lack of necessary follow-up, and other adverse consequences.
--From a statement of the American College of Medical Genetics (early 2004)
My opinion? I think that obtaining one’s own genetic information should be absolutely free of governmental regulation. The day the FDA makes consumer genotyping illegal is the day I start a genotyping service in China. Heck, I should probably get going on that, given our government’s track records on individual rights intrusion and managing healthcare. The last thing we need is more regulated information. FDA, trust your own citizens, we’re smart enough to handle a bit of information about ourselves.
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File Type: pdf ACMG DTC Statement.pdf (44.8 KB, 10 views)
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Old 06-14-2010, 12:53 PM   #2
paul z
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How soon? now!

http://www.newsinferno.com/archives/21166

The letters themselves,

http://www.fda.gov/MedicalDevices/Re.../ucm111104.htm

My opinion? Obtaining one's genotype *should* be _unregulated_, but the speculations (which amount to nothing more than present-day tarot card reading or crystal ball scrying) about what those genotypes mean, which is exactly what companies like 23andme and Knome offer through their 'Odds Calculator' or 'KnomeXplorer', absolutely *ought* to be regulated to prevent naive and ignorant individuals from making decisions on the basis of those uncertain conjectures.
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