23 And Me and the FDA Link

Derek Lowe once again provides a well thought perspective on the FDA letter. He narrows in on some of the specific details:

Moreover, the FDA wants to judge not the analytic validity of the tests, whether the tests accurately read the genetic code as the firms promise (already regulated under the CLIA) but the clinical validity, whether particular identified alleles are causal for conditions or disease.

Remember, Derek works in the pharmaceutical industry as a scientist. His opinion, more than most, takes into consideration how biotechs work with the FDA and what is considered standard operating procedure.