This letter appeared on MEDLIB-L today. I omitted name/institution:

Well, it gets one better. My "day job" is Director of Business Development
for a small biotech company with a quantitative PCR technology. I just
learned that the FDA has approved a European diagnostic/prognostic test
called "MammaPrint" by Agendia that is based on microarrays that, as a
platform, have just recently been shown by the FDA's own Microarray Quality
Control Project (see Nature Biotechnology Sept 2006) to be lacking key
quality control measures. Moreover, the FDA is in the midst of planning a
second phase of the MAQC Project which is designed to test microarray
performance on real samples (phase I was on reference material).

I am afraid more politics than science have gone in to this decision - just
as in the case of needing 3 studies to "demonstrate" the obvious.

As a scientist and as a woman I fear the state of the healthcare industry!