This grant from the National Cancer Institute is for validating molecular, cellular, and imaging markers and their assays for various applications in cancer, including detection, diagnosis, prognosis, monitoring, and predicting treatment response or resistance, as well as for cancer prevention and control. It supports investigator-initiated research covering both analytical (UH2) and clinical (UH3) validation phases. The funding targets assays designed for human samples, encompassing pharmacodynamic and toxicity markers. This opportunity also facilitates the validation of existing assays for use in other cancer clinical trials, observational, or population studies. Furthermore, it supports efforts to harmonize clinical laboratory tests, investigating assay performance and reproducibility across multiple clinical laboratories, requiring strong multidisciplinary collaboration.
Opportunity ID: 356718
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-074 |
| Funding Opportunity Title: | Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Education Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.394 — Cancer Detection and Diagnosis Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Oct 15, 2024 |
| Last Updated Date: | Oct 15, 2024 |
| Original Closing Date for Applications: | Oct 14, 2026 |
| Current Closing Date for Applications: | Oct 14, 2026 |
| Archive Date: | Nov 19, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments City or township governments Special district governments County governments Private institutions of higher education Public housing authorities/Indian housing authorities Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications to support the validation of molecular/cellular/imaging markers (referred to as “markers” or “biomarkers”) and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This FOA will support investigator-initiated research for both analytical, and clinical validation of assays to be used in cancer treatment, control, or prevention trials supported by the NCI. This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants should have assays that work on human samples and whose importance is well justified for development into clinical assays. As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance the durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. The UH2 phase of this NOFO supports analytical validation of assays for these molecular/cellular/imaging markers, which must be achieved within 2 years before assays may undergo clinical validation. The UH3 phase of this NOFO supports clinical validation of analytically validated assays for up to 3 years using well-annotated biospecimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other cancer clinical trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this NOFO will require multi-disciplinary collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientist. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-074.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 356718 Full Announcement-PAR-25-074 -> PAR-25-074-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00288410 | Jan 14, 2025 | Oct 14, 2026 | View |
Package 1
Mandatory forms
356718 RR_SF424_5_0-5.0.pdf
356718 PHS398_CoverPageSupplement_5_0-5.0.pdf
356718 RR_OtherProjectInfo_1_4-1.4.pdf
356718 PerformanceSite_4_0-4.0.pdf
356718 RR_KeyPersonExpanded_4_0-4.0.pdf
356718 RR_Budget10_3_0-3.0.pdf
356718 PHS398_ResearchPlan_5_0-5.0.pdf
356718 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
356718 RR_SubawardBudget10_30_3_0-3.0.pdf
356718 PHS_AssignmentRequestForm_4_0-4.0.pdf
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