Diagnosing cancer as early in its course as possible and developing targeted drugs for treatment result in better clinical outcomes for patients. However, the development of effective tools that enable early diagnosis and targeted therapies has been an elusive endgame. Using proteins as biomarkers has long been considered a promising clinical diagnostics approach for drug discovery and development. Some biomarkers, such as prostate-specific antigen, have been in use for many years. Many other potential biomarkers are being reported in the literature almost weekly, although few have been translated into the diagnostic arena.

In short, our progress has not been as rapid as we would like, especially given the advances in our understanding of the process by which cancer develops and becomes lethal. I believe this is about to change. This morning, in fact, during a meeting of the NCI Board of Scientific Advisors (BSA), there was rich discussion about improving both the efficiency and effectiveness of proteomic biomarker research in the United States. Specifically discussed were the need to develop animal correlates, to integrate and align existing resources such as biorepositories, and to leverage knowledge gained from work with tumors where the biology is known and apply this to the complex proteomics of serum and other body fluids.

Over the past 2 years, we have conducted an extensive planning process, analyzing U.S. and international proteomics programs, resources, and capabilities; conducting symposia with thought leaders; and seeking other disease models as possible guides for future NCI activities.

What has emerged is a consensus that, while proteins are critical to future progress in cancer biology, we will not realize clinical applications unless we take action. There is clearly the opportunity to apply biomarkers to support a host of clinical tools and capabilities, from early detection to molecular imaging probe and sensor development, to drug discovery, to rationally developed and conducted clinical trials.

As many researchers have pointed out, the field has been handicapped by barriers related to technology, reagents, bioinformatics, and systems. In particular, there is a lack of standard protocols and internal standards for current technologies to enable reproducibility of researchers' work. We also are faced with the enormous biological diversity, range, and dynamic nature of the proteins that we are attempting to measure. Other issues, like the insufficient supply of biospecimens specifically collected for protein analysis and variable approaches for data capture, analysis, and management also have slowed progress. Overall, we have heard repeatedly that what's needed is a coordinated system that no single academic or commercial entity is in a position to develop and operate.

Today, the BSA deferred action in order to further refine and develop the proposal. NCI is committed to removing barriers to success. We will continue to develop and integrate our proteomic initiatives. We plan to develop a coordinated proteomics technology development system that will provide the cancer research community with the technologies, reagents, standards, bioinformatics platforms, databases, and other resources necessary to systematically discover cancer biomarkers - in effect, to build the "base of a pyramid" that will be the foundation of the clinical development of biomarkers for early detection and diagnosis. This system will be managed with specific program milestones to ensure the best use of resources and progress.

This has been a true team effort, coupling the work of NCI staff and some of the cancer's community most eminent researchers. We look forward to continued discussions with experts and advisors around the country as we further develop this vision.

Dr. Andrew C. von Eschenbach
Director, National Cancer Institute