May2

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As a consumer and genealogist, I submitted the following comment regarding the possible strict regulation of Direct to Consumer (DTC) genetic testing at Regulations.gov.

For more information on the issues surrounding this testing, see the post “A Sad Day for Personal Genomics” at Genomes Unzipped and Daniel MacArthur’s informative blog, including this post in particular: “Last chance: let the FDA know why you want direct access to your own genome

My own comment submission is below – today is the last day to submit!

Dear Committee Members,

As a genealogist and someone interested in my own health results, I would like to make a short comment on the issues surrounding DRC genetic testing. I had my own genome analyzed by 23andme and was very pleased with the results and the format in which they were presented.

My primary reason for testing was for the possible genealogical benefits, and I look forward to my results helping me trace my lineage back as the participant database grows and more detailed haplogroup information is gleaned.

While these results were interesting as a jumping off point for dealing with my own health, as a standard consumer without any formal genetic related education I fully understand that such results are merely indicators and most findings have less of an influence over one’s health than environmental factors.

If I were to become concerned for any reason with my results I would simply take them to my health care provider to help me analyze them in context as I would with any health concern.

To me, it is quite apparent that some form of regulation of the DTC testing is necessary: maintaining transparency and the use of peer-reviewed scientific research is imperative, requirements that testing companies do not overstate results paired with penalties for companies that intentionally sensationalize and mislead consumers are common sense.

To completely limit genetic testing to doctor-ordered tests will severely lessen the number of people getting tested who might share of valuable data that can be used by all in the medical, research and genealogical communities.

Most importantly, nothing I have read has shown that such a limitation on DTC testing will have a clear benefit nor will it address any standing issue in their public use.

Please keep DTC genetic testing available to the public.

Sincerely,
John J. Tierney

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