The National Cancer Institute, Division of Cancer Preventions Cancer Biomarkers Research Group has negotiated an Interagency Agreement with NIST for biomarker validation or assay development in cancer biomarker research for the Early Detection Research Network (EDRN). National Institute of Technology (NIST), will begin a biomarker validation or assay development project on written notification from the NCI. An experimental plan that includes assay methods, source of samples/specimens, evaluation criteria, staff involved, proposed milestones, and estimated costs shall be provided by IA Holder and, if applicable, by the initiating EDRN investigator to the NCI Project Officer for approval prior to the initiation of the work. NIST will establish and maintain the infrastructure, perform quality control assays, standardize reagents for prevalidation and validation assays, and for assay development. Unforeseen technical issues that arise during analytical validation may warrant additional work. Moving to the validation phase is contingent upon acceptance of the assay by the EDRN Steering Committee and the NCI. The BRL will be responsible for standardizing laboratory assays and methodologies, instituting quality control for reagents and technologies for collaborative studies, and collaborating in other studies as directed by the NCI with advice from the EDRN SC. The Laboratory should have knowledge and practical experience with Standard Operating Procedures (SOPs) and in the evaluation of the accuracy, precision, reproducibility, and performance characteristics, for example, sensitivity, specificity, and positive and negative predictive values, of tests in multi center settings. These characteristics are important when sampling body fluids or mixed cell types where only a very small percentage of cells may exhibit the specific genetic or molecular changes. The BRL may be asked to conduct studies on a variety of assays in order to improve their performance characteristics Task 1: Validation of cancer biomarkers and development of biomarker validation assays Task 2: Mitochondrial DNA mutations as biomarkers for cancer Task 3: Telomerase as a biomarker for cancer
