Regulating DNA (tests)

I’ve mentioned before that personal genomics seemed to have hit a tipping point. Some of the evidence of that seems to be that the FDA and other regulatory agencies have taken a heightened interest in mass-market gene and genomics tests.

That is going to be the next step in our progress towards personal genomics and medicine, and one that if done right will make this part of our history a successful one. To that end, the Genomics Law Report has an interesting post: “Transparency First: A Proposal for DTC Genetic Testing Regulation.” His argument, make the registry mandatory, make transparency mandatory, is a good start.

There is also a debate going on (which I’m going to be a fence-sitter on for now) on whether the FDA should be governing these ‘Direct to Consumer’ tests. Decisiontree says no:

The controversy seems to have stirred the FDA to assert its authority – and that of physicians – over any and all medical metrics. As readers of The Decision Tree know, I have little patience for the argument that we need doctors as gatekeepers of our genetic information. This isn’t a drug, and this isn’t a device – it’s information about ourselves, as ordinary as our hair color or our waist size or our blood pressure – all things that we can measure and consider without a doctor’s permission.

Gene Sherpa says they got it all wrong:

This is not about getting access to your data.

Fine, you want a whole genome, go get it!

The FDA is not asking should people be able to go out and buy this. It is asking several other questions.

1. Is Interpretation of biometric data considered medicine?

2. Is DTCG analyzing biometric data and intending to give an interpretation of that data which indicates a disease a person has?

3. Should we regulate a system which has not given indication of their quality control if they are indeed intending to provide medical diagnosis?

4. Are these methods of obtaining human samples to derive biometric data for the intent of analyzing and providing information about disease considered medical devices?

All three are interesting and informative reads. Just thought I’d point them out. (hat tip on those last to to Daily Scan).