Thanks for your perspective, Ruth. Full disclosure -- I had a consulting contract in the curation department of 23andMe a couple of years ago, and I know how hard they work to retrieve and analyze the relevant literature for SNP associations. 23andMe does have a disclaimer on the page a visitor sees about the health reports: "The genotyping services of 23andMe are performed in LabCorp's CLIA-certified laboratory. The tests have not been cleared or approved by the FDA but have been analytically validated according to CLIA standards. The information on this page is intended for research and educational purposes only, and is not for diagnostic use." https://www.23andme.com/health/all/ This is not a hurried-up statement in response to the recent FDA letter. The earliest capture that I can retrieve is dated October 6th, 2010. http://web.archive.org/web/20101006025405/https://www.23andme.com/health/all/ Ann Turner On Mon, Nov 25, 2013 at 6:09 PM, Ruth Cattles Cottrell < ruthcottrell@verizon.net> wrote: > Full disclosure - I work for LabCorp, (parent company of NGI, CLIA approved > lab, who I believe provides the 23 raw data) - as a Quality Manager and > past > Compliance Officer and am a medical technologist. Not speaking for LCA, of > course, but personally, I see this in the same light as the situation with > patients being able to access their own lab test results. For many years, > CMS required that lab results only be given to authorized providers - > physicians who order the tests. Some states passed state laws and became > "right to know" states. In the past decade, CMS decreed that all states > were "right to know" so now we provide lab results directly to patients > including through patient portals such as the Beacon system. > > Also, beginning about 15 years ago, reference labs were faced with > "internet > testing." Clients would set up accounts with unsuspecting reference labs > and websites where anyone could go to the website, choose tests, place them > in their cart, pay by credit card and have a requisition printed to take to > a local draw station. Reference labs spent years working through this > federal compliance maze and finally it is pretty much settled with the > internet companies having CLIA approved lab directors. > > So, the real argument is whether this is a medical device OR simply > allowing > people to order and access their own results which is already occurring in > the situations I mention. Based on the open access for test results now > available, the FDA will be hard pressed to make the medical device argument > stick. > > Just my two cents worth, > Ruth Cottrell >