Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed)

The National Cancer Institute (NCI), under the National Institutes of Health (NIH), is inviting applications for the Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed) funding opportunity. This grant supports research aimed at advancing and rigorously validating novel technologies to improve the quality, handling, and integrity of cancer-relevant biospecimens. The focus is on tools, devices, assays, and methods that enhance collection, preservation, processing, and storage of samples, ultimately facilitating cancer research in areas such as biology, early detection, clinical diagnosis, treatment, and health disparities. The NCI aims to accelerate innovations that address unmet technical needs and improve sample utility across diverse cancer research contexts. Projects under this opportunity must demonstrate **proof-of-concept** with supportive preliminary data and focus on optimizing or validating emerging biospecimen technologies. The technologies should deliver substantial improvements over current methods and include clearly defined, **quantitative performance measures** to evaluate success. Proposals must not simply apply existing technologies to biological or clinical questions but must instead advance technical capabilities. Non-responsive applications, such as those focused on clinical trials, biomarker discovery, or use of existing validated technologies without further development, will not be reviewed. This funding opportunity is part of the **Innovative Molecular Analysis Technologies (IMAT) Program**, which supports cutting-edge tools and methods for cancer research. It complements earlier-stage R61 grants (RFA-CA-25-003), which focus on initial feasibility studies, whereas this **R33 mechanism** targets later-phase technology development and robust validation. Applications must address how their technology will significantly impact cancer research, potentially transform laboratory or clinical practices, and consider mitigating health disparities. Eligible applicants include higher education institutions, nonprofits, for-profits, small businesses, local and state governments, tribal organizations, foreign entities, and faith-based organizations. Applicants may submit multiple distinct applications. Application budgets are capped at **$300,000 per year** in direct costs, with a maximum project period of **3 years**. NCI expects to fund **2 awards** with a total allocation of **$900,000** for fiscal year 2026, pending appropriations. Applications are due by **April 4, 2025**, and again on **October 3, 2025**, by **5:00 PM local time** of the applicant organization. A **Letter of Intent** is encouraged 30 days before the due date. Review of proposals will occur in July 2025 and February 2026, with advisory council reviews in October 2025 and May 2026. The earliest project start dates are **December 2025** and **July 2026**, respectively. Applicants must follow NIH submission procedures via ASSIST, Grants.gov Workspace, or institutional system-to-system platforms and adhere strictly to the guidelines in the **Application Guide**. Peer reviewers will evaluate proposals based on their **significance, innovation, rigor, feasibility, and expertise/resources** of the investigators and institutions. Applications must include rigorous **performance measures** to justify the technology’s development and validation outcomes. An annual meeting of funded investigators is required to share progress and insights. For questions, applicants may contact **Kelly Crotty, Ph.D.**, at kelly.crotty@nih.gov. This opportunity aims to support transformative technologies that advance cancer research and clinical care while addressing challenges in biospecimen quality, health disparities, and accessibility.