Direct to Consumer Genetic Testing

If you didn’t catch this, it’s true.  23andMe was given FDA approval for direct to consumer genetic testing services, the FIRST.TIME.EVER.  Interestingly, the FDA hopes that this ruling will allow consumers to change lifestyle choices related to the 10 diseases 23andMe will report currently.  

I say interesting, because for many of those diseases, lifestyle choices have not been proven to affect the outcome of the genetic alteration. Seriously, how does one change the outcome of Gaucher’s disease, early-onset primary dystonia, hereditary hemophilia or hemochromatosis through personal lifestyle choices?  And really, don’t you already know from your physician through signs and symptoms that you have these diseases, like from infancy?  Maybe you decide not to have children, but I sincerely hope you talk with a genetic counselor to learn the difference between X-linked and autosomal recessive or dominant inheritance.  

Other tidbits that are interesting… this is major PRECEDENT.  According to the FDA, it intends to offer further exemptions to the premarket review…  

“ to exempt additional 23andMe GHR tests from the FDA’s premarket review, and GHR tests from other makers may be exempt after submitting their first premarket notification. A proposed exemption of this kind would allow other, similar tests to enter the market as quickly as possible and in the least burdensome way, after a one-time FDA review.”

The agency is primarily concerned, “to help ensure that they [Genetic Health Risk tests] provide accurate and reproducible results.”  The FDA will not provide exemptions for “Diagnostic Tests.”  

I appreciate the accurate and reproducible results, but really; 

How many people know the difference between a Diagnostic Test and Genetic Health Risks?

Much educating needs to be done, here’s the links;

MIT Review

FDA Press Release

And oh… 23andMe sells the data… ALL.THE.DATA!

MIT Review

Open Critique

The Science of Collaboration