Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed) | RFA CA 23 005

Opportunity Information: Apply for RFA CA 23 005

Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) funding opportunity (RFA-CA-23-005; CFDA 93.394) aimed at improving the quality, reliability, and usability of biospecimens used in cancer research and, where applicable, clinical care. The central problem this FOA targets is pre-analytical variability: the often-unavoidable changes and degradation that can occur in key molecular targets (analytes) while a specimen is being collected, processed, handled, transported, or stored. Because these early steps can distort downstream measurements, even the most advanced genomic, proteomic, metabolomic, or cellular assays can produce misleading or irreproducible results if the input specimens are compromised. This program focuses on technologies that directly reduce those pre-analytical effects or provide credible, standardized ways to detect and quantify specimen quality so researchers and clinicians can trust the data produced from those samples.

The FOA uses the R33 mechanism, which is generally positioned for projects that have already cleared major feasibility hurdles but are not yet ready for broad adoption. In practical terms, applicants are expected to have supportive preliminary data showing the concept works in a meaningful way, and the proposed work should concentrate on further development, optimization, and, most importantly, rigorous validation. The emphasis on validation reflects the goal of moving an emerging tool or method from a promising idea into something that the wider community can confidently implement. The intent is not just to invent something new, but to produce convincing evidence that it performs reliably across realistic conditions, sample types, workflows, and use cases relevant to cancer research.

Projects responsive to this opportunity can include tools, devices, instrumentation, and associated methods that preserve, protect, or stabilize biospecimen integrity, as well as approaches that establish clear verification criteria for quality assessment and quality control (QA/QC). That can mean technologies that prevent degradation of DNA, RNA, proteins, metabolites, or other targets; systems that control temperature, time-to-processing, or other environmental variables; improved collection or storage materials; or analytical and computational methods that can measure or infer specimen quality and flag compromised samples. Importantly, the FOA highlights the need for technologies that work under diverse conditions, recognizing that real-world biospecimen handling varies widely across laboratories, clinics, biobanks, and geographic settings. By reducing pre-analytical variation, these advances are expected to strengthen studies in cancer biology, early detection and screening, clinical diagnosis, treatment and therapeutic decision-making, and cancer epidemiology, while also supporting efforts to address cancer health disparities where sample handling constraints can be more pronounced.

This funding opportunity explicitly does not allow clinical trials, which signals that the supported work should focus on technology and methodology development and validation rather than testing clinical interventions or assigning human participants to intervention arms. While biospecimens may come from clinical settings and may be used to support clinically relevant research questions, the funded activities should remain within the boundaries of tool development, performance characterization, and validation for research and clinical workflow adoption rather than clinical trial execution.

Eligibility is broad, spanning many types of U.S. organizations and also allowing non-U.S. (foreign) entities. Eligible applicants include state, county, city or township, and special district governments; public and state-controlled and private institutions of higher education; independent school districts; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education); for-profit organizations (other than small businesses) as well as small businesses; and additional categories specifically highlighted such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, U.S. territories or possessions, and Indian/Native American tribal governments that are not federally recognized. This wide eligibility aligns with the FOA’s practical aim: improving biospecimen quality requires solutions that can be implemented across many different institutional contexts, including those serving populations affected by cancer disparities.

Key administrative details provided include the NIH as the sponsoring agency, the grant instrument type, and an original closing date of September 1, 2023 (with the FOA created on December 2, 2022). While an award ceiling and expected number of awards are not specified in the provided source text, the program’s overarching purpose is clear: to produce rigorously validated biospecimen science technologies that make cancer research findings more accurate, comparable, and reproducible by ensuring the samples themselves are preserved, characterized, and handled in ways that protect the integrity of the biological signals researchers and clinicians rely on.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394.
• This funding opportunity was created on 2022-12-02.
• Applicants must submit their applications by 2023-09-01. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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