Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)

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Description

This opportunity, offered by the National Cancer Institute (NCI) at NIH, funds revision applications to accelerate the clinical validation of molecular, cellular, or imaging biomarker assays developed under currently funded NCI R01 research projects. The goal is to adapt and validate these assays for use in cancer detection, diagnosis, prognosis, monitoring, prediction of treatment response, and cancer prevention/control. The program is not intended for early-stage technology development or for conducting clinical trials, but rather for advancing assays to the point where they are ready for integration into clinical trials as investigational tools.

Projects may include acquisition of well-annotated specimens from NCI-supported or other clinical trials or cohorts for assay validation. Multidisciplinary collaboration is strongly encouraged, including scientific investigators, assay developers, clinicians, statisticians, and clinical laboratory staff.

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Due Dates

• July 11, 2025
• October 15, 2025
• February 13, 2026
• July 10, 2026
• October 14, 2026

All applications are due by 5:00 PM local time of the applicant organization. Applicants are encouraged to apply early to allow time for corrections.

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Funding Amount

• Direct costs: Up to $150,000 per year
• Project period: Maximum of 3 years
• Parent grant requirement: The parent NCI R01 must be active at submission, with at least two years of support remaining (not including no-cost extensions). Requested funds cannot extend beyond the parent grant’s end date.

The number of awards depends on NIH appropriations and the number of meritorious applications.

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Eligibility

• Applicant organizations:

  • Public and private institutions of higher education
  • Nonprofits (with or without 501(c)(3) status)
  • For-profit organizations (including small businesses)
  • State, county, city, township, and special district governments
  • Independent school districts
  • Public housing authorities/Indian housing authorities
  • Native American tribal governments and organizations
  • Faith-based and community-based organizations
  • Regional organizations
  • U.S. territories and possessions
  • Non-domestic (non-U.S.) entities (foreign organizations) and foreign components of U.S. organizations are eligible

• Individual eligibility: Any individual with the skills, knowledge, and resources to carry out the proposed research as PD/PI may apply.

• Project eligibility: Only revision applications to active NCI R01 grants are allowed. The parent R01 must have at least two years of support remaining at the estimated time of award.

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Application Process

• Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
• Required registrations: Applicant organizations must be registered with SAM, eRA Commons, and Grants.gov. PDs/PIs must have an eRA Commons account.
• Application format: Follow the NIH SF424 (R&R) application instructions and the specific requirements in the funding announcement (PAR-24-304).
• Research Plan: Must include background/significance, preliminary data (with completed or near-completed analytical validation), and a detailed approach for clinical validation.
• Letters of support: Required.
• Data Management and Sharing Plan: Required for all applications.
• No clinical trials: Applications proposing clinical trials or early-stage technology development are not allowed.

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Additional Information

• Scope: Focus is on clinical validation of existing assays, not on discovery or early-stage development.
• Assay prerequisites: Assays should be analytically validated or near completion of analytical validation.
• Team composition: Multidisciplinary teams are strongly encouraged, including clinical laboratory scientists and statisticians.
• Non-responsive applications: Proposals for clinical trials, early-stage technology development, or projects outside the scope of clinical assay validation will not be reviewed.
• Contact NCI program staff if you are unsure whether your project fits the scope.

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External Links

• Full Funding Announcement (PAR-24-304)
• NIH Application Guide
• NCI Division of Cancer Treatment and Diagnosis
• Grants.gov Opportunity Listing

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Contact Information

For additional contacts, see the full announcement Section VII.

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