The FDA considers the company’s service a “medical device” and therefor needs regulatory imageclearance.  Risk assessments and safety is the grounds for the FDA letter.  Cancer tests are the big concern with saliva testing.

False positive results is where the FDA is looking as they state a patient could undergo screenings and surgeries that are not in fact necessary.  In addition false negatives are also addressed by the FDA stating that a patient would not undergo appropriate testing and diseases could be missed.  It sounds like it’s a 501k time application perhaps to establish clinical boundaries and values.  There has been ongoing meeting between the FDA and the company. 

Update:  If you have not read this article, do it…see how data selling makes big riches for Google and others as well,  Scientific American article from Professor Siefe, mathematician at NYU gives his take and it’s aimage good one..full story at the link and a couple preview paragraphs below…

23andMe Is Terrifying, But Not for the Reasons the FDA Thinks

“But as the FDA frets about the accuracy of 23andMe’s tests, it is missing their true function, and consequently the agency has no clue about the real dangers they pose. The Personal Genome Service isn’t primarily intended to be a medical device. It is a mechanism meant to be a front end for a massive information-gathering operation against an unwitting public.

What the search engine is to Google, the Personal Genome Service is to 23andMe. The company is not exactly hiding its ambitions. “The long game here is not to make money selling kits, although the kits are essential to get the base level data,” Patrick Chung, a 23andMe board member, told FastCompany last month. “Once you have the data, [the company] does actually become the Google of personalized health care.”

While the FDA concentrates on the question of whether 23andMe’s kit is a safe and effective medical device, it is failing to address the real issue: what 23andMe should be allowed to do with the data it collects. For 23andMe’s Personal Genome Service is much more than a medical device; it is a one-way portal into a world where corporations have access to the innermost contents of your cells and where insurers and pharmaceutical firms and marketers might know more about your body than you know yourself. And as 23andMe warns on its website, “Genetic Information that you share with others could be used against your interests. You should be careful about sharing your Genetic Information with others.”

Also scroll down to the footer to watch “Context is Everything” from Professor Siefe or visit the Algo Duping page for even more videos on how all of this takes place and the huge profits made from data selling.  This is what I think could be done and my campaign to license (start an index) on all the data sellers out there as it’s really totally out of control. FTC thus far as well as Congress have been pretty useless and have not shown any teeth.   BD

FTC Tries to Bring Strong Case for Consumer Protections With Use of Data–But Nothing About Creating IT Infrastructure Path to Allow Regulation–Gov Can’t or Won’t Model?


(Reuters) - The U.S. Food and Drug Administration has warned 23andMe Inc, a company backed by Google Inc, to halt sales of its genetic testing services because they have not received regulatory clearance.

23andMe, which was founded in 2006 by Anne Wojcicki with the backing of Google, sells DNA testing services that the company says detect a range of genetic mutations and provide information about a person's health risks. Wojcicki recently separated from her husband, Sergey Brin, a co-founder of Google.

In a warning letter dated November 22 and released on Monday, the FDA said it considers the company's product a medical device that therefore requires regulatory clearance, "as FDA has explained to you on numerous occasions."

The agency said that if the company's risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo preventative surgery, intensive screening or other potentially risky procedures. A false negative, on the other hand, could result in a failure to recognize actual risk.

http://www.reuters.com/article/2013/11/25/us-23andme-fda-warning-idUSBRE9AO0MG20131125

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