|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|
|Thread||Thread Starter||Forum||Replies||Last Post|
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|23andMe: FREE* genotyping, today only!||Michael.James.Clark||Personalized Genomics||0||04-11-2011 03:52 PM|
|deCODEme opens sample data set, check it out!||ECO||Personalized Genomics||0||01-21-2008 08:58 AM|
|deCODEme service updates, Nov. 23||ECO||Personalized Genomics||0||11-23-2007 08:50 AM|
|Initial Review of deCODEme Personal Genomics Service||ECO||Personalized Genomics||3||11-16-2007 06:40 PM|
|11-23-2007, 04:47 PM||#1|
Location: SF Bay Area, CA, USA
Join Date: Oct 2007
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):
|06-14-2010, 12:53 PM||#2|
Location: New York, NY
Join Date: Aug 2008
How soon? now!
The letters themselves,
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.