Molecular Biomarkers have become a major focus of disease management and drug development, particularly in oncology. This prototypic study will identify the existing biomarkers in breast cancer and classify them in terms of disease progression and also as to their clinical vs. research use.
Biomarkers are typically used to establish presence or absence of disease, genetic risk and endpoints for clinical trials. The Human Genome Project has identified a large number of potential targets for drug development, but without the necessary validation for implementation in drug discovery programs. Our perspective of disease has evolved from simply the difference between non-disease and disease states as we recognize the progression from non-disease, potential genetic risk, diagnosis, disease staging, disease stratification, therapeutic selection, recurrence and outcome as elements of disease progression. There is a need to understand the relationship between biomarkers and their association with these components of disease to optimize their utility in both research and clinical settings. In addition, many biomarkers have been noted in research environments without entering the formal FDA approval process to enable clinical application. We believe that this level of definition and clarification would be useful for the drug and diagnostic industries and healthcare, in general, and would like to use biomarkers in breast cancer as a prototype to show the potential value of such an undertaking.
We believe that the results of this prototype can help to guide future development in both the research and clinical arenas by setting standards for understanding the role of these important chemical and biomolecular agents.