A Biospecimen Core Resource (BCR) can serve various functions in support of research, encompassing biospecimen collection, processing, storage and distribution of biospecimens for research. The National Cancer Institute (NCI) supports a number of projects that require the use of a Biospecimen Core Resource (BCR) both now and in future years. In previous years, a BCR has been critical for NIH and NCI-funded biospecimen collection programs, supporting scientific programs such as the NIH Common Fund Genotype-Tissue Expression (GTEx) project, the NCI Biospecimen Pre-analytical Variables (BPV) programs, the NCI Clinical Proteomic Tumor Analysis Consortium (CPTAC), and The Cancer Genome Atlas (TCGA). Both GTEx and BPV required a BCR to build and distribute specialized biospecimen collection kits, receive, process, store and distribute biospecimens, as well as to perform histology staining and imaging and data transfer, all critical components to the success of the projects. Several organizations play a role in biospecimen processing and coordination for NCI programs under the National Clinical Trials Network (NCTN). NCI programs such as CPTAC that require a BCR may not require processing of samples in Clinical Laboratory Improvement Amendment (CLIA)-certified facilities, if they do not require return of results to patients and their providers. Other projects, for example the Cancer Moonshot Biobank program, do require sample receipt and processing in a CLIA-certified laboratory and shipment to other CLIA laboratories for performance of clinical biomarker assays which are then returned to patients and providers to inform medical care. Sample receipt and processing for clinical trial biospecimens, for example samples from research participants in the Molecular Analysis for Therapy Choice (MATCH) clinical trial, also must be performed at CLIA-certified laboratories.
Currently the NCI has developed a number of programs under the Beau Biden Cancer Moonshot Initiative. The programs are intended to accelerate cancer research in key strategic areas that were recommended by a “Blue Ribbon Panel” of cancer research experts. Core elements of the recommendations include the rapid acceleration of progress in cancer research by addressing critical scientific questions, and the need for nationwide participation in research by patients that represent the diversity of the U.S. population. The Cancer Moonshot Biobank has been designed to assist with the research needs of new initiatives developed under the Cancer Moonshot initiative. The primary objectives of the Cancer Moonshot Biobank are to engage with patients and their medical providers to donate longitudinal tumor biospecimens and matched blood and to distribute the biospecimens, derivatives and associated data to qualified researchers. Research participants will be enrolled and biospecimens and associated data collected for at least 4-5 years; operations may continue for additional years if funding allows. To accomplish the objectives, the Cancer Moonshot Biobank utilizes a central BCR contracted to perform biobanking and pathology quality control. The BCR engages with other key project players including community hospitals and other medical institutions, designated as Biospecimen Source Sites (BSS), who engage a diverse participant population in this longitudinal study. The BCR must support Saturday specimen receipt and processing for tissue and blood so that patients who have procedures (surgeries, biopsy procedures and blood draws) on a Friday may participate in NCI-sponsored research. The BCR must also work with NCI to make the biospecimens and associated data available to researchers to accelerate cancer research progress.
