The National Cancer Institute (NCI) is offering this grant to accelerate the adoption and validation of high-quality molecular, cellular, and imaging biomarkers and their assays. This grant is for validating established markers essential for cancer detection, diagnosis, prognosis, monitoring treatment response or resistance, prevention, and control, including pharmacodynamic and toxicity markers. Applicants must have analytically validated assays in specimens similar to their intended clinical use. The UH3 mechanism supports clinical validation for up to three years using existing clinical trial specimens. This funding opportunity also encourages harmonizing clinical laboratory tests and investigating assay performance across multiple labs. Projects require multi-disciplinary collaboration and are intended for validating assays for integration into clinical studies, not early technology development or conducting new clinical trials.
Opportunity ID: 356717
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-075 |
| Funding Opportunity Title: | Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials 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: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts Private institutions of higher education Special district governments Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) Small businesses City or township governments County governments For profit organizations other than small businesses State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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) intends to accelerate the adoption and 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 NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants to this NOFO must have an assay(s) whose performance has been analytically validated in specimens similar to those for the intended clinical use of the marker(s) and assay(s). 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 UH3 mechanism will support the clinical validation of established assays for up to 3 years using specimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other 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 interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials but is intended for validation of assays to the point where they could be integrated into clinical trials/studies as investigational assays. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-075.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 356717 Full Announcement-PAR-25-075 -> PAR-25-075-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 | PKG00288411 | Jan 14, 2025 | Oct 14, 2026 | View |
Package 1
Mandatory forms
356717 RR_SF424_5_0-5.0.pdf
356717 PHS398_CoverPageSupplement_5_0-5.0.pdf
356717 RR_OtherProjectInfo_1_4-1.4.pdf
356717 PerformanceSite_4_0-4.0.pdf
356717 RR_KeyPersonExpanded_4_0-4.0.pdf
356717 RR_Budget_3_0-3.0.pdf
356717 PHS398_ResearchPlan_5_0-5.0.pdf
356717 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
356717 RR_SubawardBudget30_3_0-3.0.pdf
356717 PHS_AssignmentRequestForm_4_0-4.0.pdf
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