The goal of this program is to improve patient outcomes by translating information from comprehensive characterization of molecular alterations in a patient's tumor and associated tissues to clinical application. A critical component of clinical application is to accelerate the evaluation of molecular alterations in clinical tumor specimens and the development and evaluation of the clinical assays needed to these alterations. This initiative will provide resources focused on the development, optimization and validation molecular profiling procedures and predictive assays based on those profiles for use in clinical trials. Advances in our understanding of the biology of cancer and in the tremendous enabling technologies derived from the Human Genome Project that allow the comprehensive characterization of individual tumors promise to change the practice of medicine. The translation of these findings to effective clinical tools has been extremely inefficient. Many components of the molecular profiling/diagnostic assay/drug development pipeline are not readily available. Continuing to focus on genetic research will improve the knowledge of causal pathways, and ultimately allow translation into new methods of therapy, prevention, and early detection. Molecular characterization of tumors is generally done in the context of specific research studies. There is a need to initiate a program to facilitate the characterization of a much wider range of patients'tumors and to support the research needed to facilitate use of that information clinically. A second component of the pipeline is the final development, optimization and validation of the clinical assays to be used in the individualization of cancer therapy. Implementation of Molecular Characterization Centers will involve active collaboration amongst the components of NCI that have all of the necessary expertise in each of the critical aspects of the project. These centers will also require multiple technologies to build a high through-put research capacity with sufficient scientific range. Under the time line of the ARRA, initial development of the molecular characterization/diagnostic assay pipeline will be completed. This will ensure that the final development, optimization and validation of the clinical assays can be completed expeditiously. In addition, it will facilitate the validation of assays that are proposed as integral assays in clinical trials. The proposed Molecular Characterization/Clinical Assay Development Program will include an Assay Development Center (ADC) at NCI and an Assay Development Network (ADN) in the extramural community. Together these centers will create a process to efficiently develop diagnostic tools that will address clinical needs, including co-development of targeted agents and predictive markers. Initially, the emphasis will be on molecular characterization assays proposed for use in clinical trials. The ADC and ADN will provide the resources to carry out the necessary assay optimization and evaluation.
