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

Funding Agency:
National Institutes of Health

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) encourages revision applications (formerly called "competing revisions") from currently funded NCI R01 research projects. The applicants should propose projects that are expected to accelerate the pace of translation of NCI-supported methods/assays/technologies (referred to as "assays") to the clinic. Specifically, the focus of applications submitted in response to this NOFO should be on the adaption and clinical validation of molecular/cellular/imaging markers (referred to as "markers" or "biomarkers") for cancer detection, diagnosis, prognosis, monitoring, and prediction of response in treatment, as well as markers for cancer prevention and control. Applications may support the acquisition of well-annotated specimens from NCI-supported or other clinical trials or observational cohorts/consortia for the purpose of clinical validation of the assay. Research projects proposed in response to this NOFO encourage multidisciplinary interaction among scientific investigators, assay developers, clinicians, statisticians, and clinical laboratory staff. Clinical laboratory scientist(s) and statistical experts are highly encouraged to comprise integral parts of the application. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials, but rather the adaption and validation of assays to the point where they could be integrated into clinical trials as investigational assays/tools/devices.


  • Renewal / Resubmission / Revision Due Date(s):  February 20, 2024; July 9, 2024; Oct 8, 2024; Feb 14, 2025; July 11, 2025; Oct 14, 2025; Feb 13, 2026; July 10, 2026; Oct 13, 2026

PAR-24-047 Expiration Date  October 14, 2026

Agency Website



Amount Description

Application budgets are limited to $150,000 in direct costs in any single year.  

The parent grant must be active when the application is submitted. There must be a minimum two years of support remaining on the parent award (not to include a no cost extension) at the estimated time of award. If a no-cost extension is needed on the parent grant, it must be in place before the revision application is submitted. The maximum project period is 3 years.   

    Funding Type





    Engineering and Physical Sciences
    Medical - Clinical Science
    Medical - Translational

    External Deadline

    July 9, 2024