as can probably be infered from my post, I am somewhat new to the story. I didn't know one had to be a full out expert on a stock to post questions and opinions in search of education from others. Having said that, the issue indirectly is about validation. My understanding is that the FDA is trying to regulate the approval of these types of diagnostics, specifically trying to figure out the trials required to prove the ability/validation of these tests. If you are familiar at all with the biotech or medtech space, you will know that these products generally need placebo controlled, blinded, randomized, PROSPECTIVELY defined criteria in order to confirm that the drug, device, (or diagnostic) is safe and effective. Since you seem to know so much about Oncotype DX, then you will know that the approval was base on retrospecitive data drugging that found a correlation. That doesn't follow scientific rigor. I can't tell you how many times a company's drug failed in achieving its primary endpoint to turn around and tell investors that "we failed, BUT, if you analyze our data this way it was very positive". The FDA could regulating these test and require that the company has to go back and do formal prosepective trials for Oncotype DX and, moreover, that all their follow on products will haev to undergo similar testing which takes a long time.
Indeed I think it is a very valid question. As you may recall at one point FDA did send a message asking for more screening for the Genomic test...I did got out from my position too early, but I still think that the current price is a buble.