There are few, if any, sufficiently sensitive and specific biomarkers known today that could be used as diagnostic or prognostic imaging contrast agents, targeting agents, or as serum markers to detect clinically significant breast disease. No molecular techniques are as yet directly applicable to breast disease imaging. Academic research in diagnostic and prognostic breast imaging is limited by insufficient funding of focused research projects, by limited access to the newest and potentially most useful imaging technologies due to insufficient funding, and by a scarcity of scientists interested in this translational, cross-disciplinary research. The few prognostic and predictive biomarkers identified to date are individually weak and often present in heterogeneous combinations within the same tumor. We do not fully understand how to evaluate and interpret this complex information.
Statistical models are still in development.
It is unclear how to analyze and interpret the enormous amount of data being generated from new high throughput technology such as genetic arrays, especially as it relates to specific clinical problems such as diagnostic and prognostic biomarkers in breast cancer. Human breast tissue samples for research are scarce, particularly samples of premalignant disease. Samples from diverse populations are needed for correlative studies necessary to identify, characterize, and validate diagnostic, prognostic, and predictive biomarkers. Although fixation of breast tissues is usual, this often precludes RNA and some DNA analyses. Legal and ethical barriers to obtaining human tissue for biologic or clinical studies in general are complex, escalating, and geographically diverse based on local and state regulations.