I posted that comment on NYT then submitted this article to HN. I used to work in the medical laboratory business before getting into software development. I do

I posted that comment on NYT then submitted this article to HN. I used to work in the medical laboratory business before getting into software development. I do not think 23 and me is going to escape enforcement from the FDA. The comments they made to NYT were about the fact that the FDA has to look at each test individually to determine if it can be CLIA waived. They imply that this is an archaic way of doing things as they are testing millions of correlations, and compare it with the challenges in the tech community with slow regulatory change. They are wrong about this. The FDA does have to evaluate every diagnosis that they are making as it is that.. a diagnosis. Diagnoses that are going straight to the consumer have an even higher bar to meet not unlike a drug becoming OTC. Medical laboratories are not allowed to perform direct to patient testing for non waived tests. The purpose of this is that they do not want patients to interpret tests incorrectly where there is gray area, and possibly make adverse decisions based on the diagnosis. http://wwwn.cdc.gov/CLIA/Resources/WaivedTests/default.aspx http://wwwn.cdc.gov/CLIA/Resources/WaivedTests/default.aspx