Department of Health
and Human Services (HHS)
and Human Services (HHS)
NOT-CA-21-051 - Notice of Intent to Publish a Funding Opportunity Announcement: Early Detection Research Network (EDRN) – Clinical Validation Centers
NOT-CA-21-052 - Notice of Intent to Publish a Funding Opportunity Announcement: Early Detection Research Network (EDRN) – Data Management and Coordinating Center
National Cancer Institute (NCI)
The National Cancer Institute (NCI) plans to publish a Funding Opportunity Announcement (FOA) for the establishment of the Biomarker Characterization Centers (BCCs) of the Early Detection Research Network (EDRN). The EDRN is a national infrastructure to discover, develop, and validate biomarkers and imaging methods for early cancer detection and risk assessment. BCCs will (1) discover, develop, characterize and test new biomarkers or refine existing biomarkers, (2) develop, refine and/or standardize biomarker assays, (3) provide resources and support for the validation of biomarkers developed by the EDRN, and (4) participate in collaborative projects with other EDRN laboratories and centers.
The other two scientific units of the continuing EDRN program are the Clinical Validation Centers (CVCs), which will conduct clinical research on the validation of biomarkers and will serve as resource centers for the Network by participating in collaborative biomarker validation studies with EDRN BCCs; and the Data Management and Coordinating Center (DMCC), which will support statistical and computational analyses, informatics infrastructure, study design, coordination and management of EDRN-sponsored biomarker validation studies, and the coordination of Network-wide meetings and workshops.
This Notice is released to provide potential applicants with time to consider scientific topics for this program, plan an integrated BCC, and develop the necessary collaborations for the multi-disciplinary, multi-Principal Investigator FOA. Companion notices for the CVCs and the DMCC are NOT-CA-21-051 and NOT-CA-21-052, respectively.
The BCC FOA is expected to be published in the Spring of 2021 with an expected application due date in the late Summer 2021.
The BCC FOA will utilize the U2C activity code for the research projects. Details of the planned FOA are provided below.
Each BCC will consist of an Administrative Core and two highly integrated research components, a Biomarker Developmental Laboratory (BDL), and a Biomarker Reference Laboratory (BRL). The BDL will discover, develop, characterize and test new biomarkers (e.g., genomics and/or proteomics and/or epigenomics and/or metabolomics etc.) or refine existing biomarkers, and (2) the BRL will (i) develop, refine and/or standardize biomarker assays and (ii) provide resources and support for the validation of biomarkers developed by the EDRN. Both BDL and BRL components will participate in collaborative projects with other EDRN laboratories and centers. Network collaborative projects will initiate in the second year of the grant, which is reflected in the increased budget for Years 2-5 below.
Data science is poised to play a major role for new or improved risk stratification, early detection, and precision prevention strategies. It is desirable that the biomarker discovery/development approach includes data mining or in silico approaches to support and/or complement discovery efforts. It is also encouraged that computational/mathematical data modeling approaches be used to predict the translational efficacy of the proposed biomarkers as this will ensure a greater chance of success in downstream validation phases and reaching the clinic. Inclusion of data modeling can enhance the discovery efforts by identifying opportunities for precision screening/early detection, provide a better understanding of real-world clinical settings and needs, and also support the development of statistical modeling and simulation models to evaluate the impact of the proposed biomarker tests.
It is encouraged that partners from for-profit sector, biotech, industry, or diagnostic companies be included in the BCC proposal. Such partnerships can be for biospecimens, reagents, protocols, assay development and/or refinement, technologies and/or any other resources. The BRL component must have access to a CLIA-accredited laboratory andbe willing to take the test(s) forward for FDA approval.
The FOA will be open to all qualified applicants, including new and early-stage investigators, who can establish and lead multi-disciplinary, multi-institutional, multi-Principal Investigator research projects to enable the fulfillment of the intended program goals.
More details will be outlined in the forthcoming FOA.
NCI intends to commit $9.5 million in FY 2022 and $13.5 million in FY 2023-2026.
Up to 18.
Each U2C application budget will be limited to $500,000 (direct cost) for Year 1 (FY 2022), and to $725,000 per year (direct cost) for Years 2-5 (FY 2023-2026).
93.393;93.394
Applications are not being solicited at this time.
Please direct all inquiries to:
Sudhir Srivastava, Ph.D., M.P.H.
National Cancer Institute (NCI)
240-276-7028
Sharmistha Ghosh-Janjigian, Ph.D.
National Cancer Institute
Telephone: 240-276-7122
Email: ghoshjanjigias@mail.nih.gov