Genetic Testing and the FDA

Ann Bartlett Health Guide
  • A few weeks ago, I wrote a blog about TrialNet, Genetic Testing and Diabetes, after I had read a provocative article on 23andMe and their $99 genetic test in Fast Company. At the time, my feelings about 23andMe were mixed as to whether this was a service to people wanting to know more about their genetic make up.


    On Nov 22, 2013, the FDA issued a warning letter to 23andMe, halting all sales of its $99 genetic test for several reasons. Some of their concerns are false-positive tests, and that the data could be damaging to a patient who seeks out risky medical practices based on the results.

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    Years ago, the FDA used the same argument against selling blood glucose meters to patients with diabetes. I believe that the FDA is wrong in saying that data in the hands of patients will do damage. At the end of the day, the data obtained by blood glucose meters has helped millions of people living with diabetes to live with fewer complications and to have better information to provide their doctors. Not to mention the data helps to guide the industry to provide better guidelines and drive innovation for patients.


    Op-Eds in many news organizations are both for and against the FDA’s action. But the issue between the FDA and 23andMe is that 23andMe is selling this product for services for which the FDA has not approved. It's marketed to test your genetics for health risk factors... yet it’s also a genealogy test kit that allows you to trace your origins. 


    The tracking of information isn’t my problem with 23andMe, it is the lack of transparency about the use of the data, or even what labs are doing the testing. Is the testing done here in the U.S., where privacy law is upheld, or is it tested overseas, say China, for example, where the government owns quite a few genetic testing laboratories? And, who is buying the information? The lack of transparency from 23andMe actually freaks me out a little.


    If you are a genealogy fan, check out the Human Genome Project at National Geographic. I think National Geographic did an amazing job making this transparent and a real learning tool for participants! This is a great example of what 23andMe might want to consider and shows the kind of transparency I’m comfortable with.


    Genetic testing is becoming all the rage, but I also believe the FDA is right in halting the sale of the 23andMe genetic test kit, for the moment. The FDA needs to develop guidelines for companies like 23andMe. In addition, the FDA needs to think about what is cause for reviewing a device that expands its use, which is the hook that caught 23andMe. If every new twist in the genetic world has to go through FDA approval processes again and again and again, then the FDA system will grind to a halt, attempting to keep up with the momentum of innovation.  


    In the meantime, if you are a person looking to contribute your DNA to science, talk with your doctor and find out where your DNA will be of most use. If your doctor doesn’t know, check with some of the non-profits, who will surely have contacts for consideration!

Published On: November 27, 2013