Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed)

The National Institutes of Health, through the National Cancer Institute, has released a funding opportunity titled Integrating Biospecimen Science Approaches into Clinical Assay Development under funding opportunity number PAR-25-325. This program aims to support research addressing preanalytical variability in biospecimen handling that impacts the development and validation of clinical biomarker assays. The funding opportunity uses the U01 Research Project Cooperative Agreement mechanism and does not allow clinical trials. The program focuses on tumor tissue biopsies, blood biospecimens used as liquid biopsies, and other biospecimens such as cerebrospinal fluid, urine, feces, tissue swabs, and saliva. Research will investigate how variations in biospecimen collection, processing, and storage conditions affect analytical performance and reproducibility of clinically relevant biomarkers across various testing platforms. The overarching goal is to expedite the development of biomarker-based clinical assays through evidence-based standardization of biospecimen handling practices. Applications must address preanalytical challenges for specific biomarker assays, including emerging or established biomarkers intended for use in clinical trials. Research projects should focus on solid tumor biopsies, such as fine needle aspirates and core biopsies, as well as liquid biopsies targeting circulating tumor cells, cell-free DNA, microRNA, exosomes, and other metabolites. Proposed studies should evaluate how preanalytical factors impact assay performance, sensitivity, and reproducibility, and identify strategies to mitigate variability. Examples include optimizing biopsy preservation methods, managing freeze-thaw cycles, and standardizing blood collection protocols. Eligible applicants include public and private institutions of higher education, nonprofits, for-profit organizations, state and local governments, tribal governments, foreign organizations, and U.S. territories. Foreign components of U.S. organizations may also apply. Applicant organizations must complete required registrations in SAM.gov, eRA Commons, and Grants.gov. Program directors and principal investigators must hold eRA Commons accounts. Application budgets are limited to two hundred fifty thousand dollars in direct costs per year, with a maximum project period of five years. Submission deadlines occur three times annually: February 4, June 4, and September 10. Applicants must submit a letter of intent 30 days prior to the application due date. Scientific merit reviews will occur approximately four months after submission, with advisory council reviews and funding decisions taking place within six months. The review process will emphasize the project’s significance, innovation, rigor, and feasibility. Specific considerations include the project’s potential to improve assay reliability, address preanalytical variability, and advance clinically relevant biomarker assays. Proposals must demonstrate clear study objectives, statistically justified designs, and robust plans for quality control of biospecimens and analytical platforms. Multidisciplinary teams with expertise in oncology, pathology, radiology, molecular biology, and biostatistics are encouraged to apply. Successful applicants will join a collaborative U01 research network coordinated by NCI program staff. The network will promote resource sharing, standardize biospecimen practices, and generate data to support clinical trial optimization. A steering committee comprising principal investigators, NCI staff, and subject matter experts will oversee network activities and promote collaboration across funded projects. Applications must be submitted electronically through ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. NIH policies for data management, sharing, and reporting will apply. For more information or assistance, applicants may contact designated program staff or grants management specialists at the National Cancer Institute.