FDA cracks down on DTC genetic testing

There's hardly a genetics blog about that hasn't reported this news already, but I thought I'd jump on the bandwagon and chime in with my 2 pence. The fact of the matter is that letters have been issued to several DTC genetic testing companies; 23andMe Inc, deCode Genetics, Knome Inc, Navigenics, and Illumina, in which they have been asked to submit their genetic testing for review by the FDA. The FDA have justified their actions by stating from the companies websites, which they claim are used as medical diagnostics. In particular with respect to pharmacogenetic markers of Warfarin and clopidogrel that are tested by 23andMe:

23andMe has never submitted information on the analytical or clinical validity of its tests to FDA for clearance or approval. However, your website states that the 23andMe Personal Genome Service™is intended to tell patients in advance how they will respond to certain medications including warfarin and clopidogrel. It also states that the data generated from the 23andMe Odds Calculator, a feature ofthe 23andMe Personal Genome Service™, includes the contribution of single-nucleotide polymorphisms (SNPs) to disease risk. Consumers may make medical decisions in reliance on this information.

Each company has been selected based on the various services they offer, but for me there it seems that their action can be called into question for several reasons. The first is the recent sample mix-up from 23andMe last week. Some may see the FDA's actions as reactionary and PR-motivated, afterall it is not a matter of whether DTC genetics are used for medical purposes. Nor would their registration as such prevent such mix-ups. I trust that all of these personal genetics companies have strict quality control measures in place becuase of the potentially sensitive information they are dealing with.
The second point is that, whilst I agree DTC genetics needs to be regulated, it should not be as medical diagnostics. Unless people are suddenly using this information to self-medicate then it is not being used for the purposes that the FDA state.

What the FDA should be doing is setting up a division for DTC regulation to prevent the sham-companies from scheming money out of the unwitting public and setting the standards for future personal genomics companies.

This could potentially damage personal genomics if the FDA handle it badly. If I were the CEO's of these DTC companies I would perhaps propose a compromise so that the proper, and appropriate regulation can be implemented; one that does not place personal genetics under the misnomer of medical diagnostics.