Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)

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Description

This opportunity, offered by the National Cancer Institute (NCI) at NIH, funds the analytical and clinical validation of molecular, cellular, or in vitro imaging markers (biomarkers) and assays for cancer research. The goal is to support the development of robust, validated assays that can be used in NCI-supported clinical trials, observational studies, or population studies for cancer detection, diagnosis, prognosis, monitoring, prediction of treatment response or resistance, and cancer prevention/control.

The program uses a two-phase cooperative agreement mechanism (UH2/UH3):

• UH2 phase (up to 2 years): Analytical validation of assays, including accuracy, precision, sensitivity, specificity, reportable range, reference intervals, and quality control.
• UH3 phase (up to 3 years): Clinical validation of analytically validated assays using well-annotated biospecimens from retrospective or prospective clinical studies.

Projects may also focus on harmonizing laboratory tests and evaluating assay performance and reproducibility across multiple clinical laboratories. The program is not intended for early-stage technology development or for conducting clinical trials, but rather for bringing existing assays to the point where they are ready for integration into clinical research.

Multi-disciplinary collaboration is required, involving scientific investigators, oncologists, statisticians, and clinical laboratory scientists.

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Due Dates

• June 11, 2025: Application due date (New)
• July 11, 2025: Application due date (Renewal/Resubmission/Revision)
• October 15, 2025: Application due date (New, Renewal/Resubmission/Revision)
• February 13, 2026: Application due date (New, Renewal/Resubmission/Revision)
• June 10, 2026: Application due date (New)
• July 10, 2026: Application due date (Renewal/Resubmission/Revision)
• October 14, 2026: Application due date (New, Renewal/Resubmission/Revision)
• Expiration Date: October 15, 2026

All applications are due by 5:00 PM local time of the applicant organization.

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Funding Amount

• UH2 Phase: Up to $275,000 direct costs total (no more than $200,000 in any one year; up to 2 years)
• UH3 Phase: Up to $250,000 direct costs per year (up to 3 years)
• Project Duration: Maximum 5 years (2 years UH2 + 3 years UH3)
• Funding Instrument: Cooperative Agreement (substantial NIH programmatic involvement)

The number of awards is contingent on NIH appropriations and the submission of a sufficient number of meritorious applications.

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Eligibility

Eligible applicants include:

• Public and private institutions of higher education (U.S. only)
• Nonprofits (with or without 501(c)(3) status), other than institutions of higher education
• For-profit organizations (including small businesses)
• State, county, city, township, and special district governments
• Native American tribal governments and organizations (federally recognized and other)
• Independent school districts
• Public housing authorities/Indian housing authorities
• Faith-based or community-based organizations
• Regional organizations
• U.S. territories and possessions
• Eligible agencies of the federal government

Not eligible: Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations. However, foreign components (as defined in the NIH Grants Policy Statement) are allowed.

Note: Applicant organizations must complete all required registrations (SAM, eRA Commons, Grants.gov, etc.) before applying.

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Application Process

• Applications must be submitted electronically via Grants.gov using the NIH ASSIST system, Grants.gov Workspace, or an institutional system-to-system solution.
• Follow the NIH How to Apply - Application Guide and the specific instructions in the funding announcement.
• All required forms and attachments must be completed, including:
  • SF424 (R&R) forms
  • PHS 398 Research Plan (with separate aims for UH2 and UH3 phases)
  • Data Management and Sharing Plan
  • Human Subjects and Clinical Trials Information (if applicable)
  • Budget Justification
  • Letters of Support
• Applications must address both the UH2 (analytical validation) and UH3 (clinical validation) phases, with clear milestones for transition.

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Additional Information

• Scope: Projects must focus on validation of existing assays (not early-stage technology development or biomarker discovery).
• Assays: Must be functional in human samples and justified for clinical development.
• Clinical Trials: This opportunity does not support the conduct of clinical trials.
• Collaboration: Multi-disciplinary teams are required, including clinical investigators, laboratory staff, statisticians, and (optionally) commercial partners.
• Data Sharing: All applicants must include a Data Management and Sharing Plan.
• Review Criteria: Emphasis on significance, innovation, rigor, feasibility, and the potential for broad adoption in clinical research.

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External Links

• Full Funding Announcement (PAR-25-074)
• NIH How to Apply - Application Guide
• NIH Data Management and Sharing Policy
• NIH Grants Policy Statement
• NIH eRA Commons
• Grants.gov Opportunity Listing

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Contact Information

For additional contacts and details, see Section VII. Agency Contacts in the full announcement.