Monday, July 19, 2010

The FDA and me, and you, and our genetic information

The FDA is holding a public meeting on "Oversight of Laboratory Developed Tests (LDTs)" on my campus (University of Maryland) today and tomorrow. Registration is closed, but it's possible to view the proceedings via webcast (here). I am doing that now (I'm watching Judith Wilber right now). I stopped by briefly this morning and hope to go back tomorrow afternoon. The topic has been in the news a bit lately (see my links under right to know on delicious), and there are legitimate issues to address.

I have expressed my opinion in favor of our right to know our own genetic makeup on my blog and will only briefly restate those arguments further here. My preference would be that oversight and approval of genotype "tests" (including whole-genome sequencing) be limited to technical standards (Are the genotype results are accurate?), but that rules and oversight are appropriate for interpretation and guidance. A genotype is information, and it may be best to separate genotyping tests from the recommendations based on them to the extent possible. Asking a genotyping service to imagine the clinical and medical utility of their tests is a bit like asking the manufacturer of bathroom scales to prove that knowing one's weight is medically useful. Clinical utility should not be a criterion for genotype tests that provide accurate and reliable information. I'm not saying that the FDA should not protect consumers from bad advice, but that in the case of genotype information, this can and should be separated from the regulation of tests per se.

No comments: