The National Cancer Institute (NCI) offers this grant to accelerate the translation of NCI-supported assays and technologies into clinical use. Specifically, this funding aims to support the adaptation and rigorous clinical validation of molecular, cellular, and imaging biomarkers. These validated markers will be critical for improved cancer detection, diagnosis, prognosis, treatment response prediction, monitoring, control, and prevention. Projects may include acquiring well-annotated specimens from existing clinical trials or observational cohorts for validation purposes. The grant strongly encourages multi-disciplinary collaboration among scientific investigators, assay developers, clinicians, and statistical experts. Importantly, this opportunity is not for early-stage technology development or new clinical trials, but rather for maturing validated assays to integrate as investigational tools within future clinical trials.
Opportunity ID: 356680
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-24-304 |
| Funding Opportunity Title: | Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| 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 10, 2024 |
| Last Updated Date: | Oct 10, 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: | State governments Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments For profit organizations other than small businesses Native American tribal governments (Federally recognized) City or township governments Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Special district governments |
| 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | Through this Notice of Funding Opportunity (NOFO) is to accelerate the pace of translation of NCI-supported methods/assays/technologies (referred to as “assays”) to the clinic. Specifically, the focus of this NOFO is on the adaption and clinical validation of molecular/cellular/imaging markers (referred to as “markers” r “biomarkers”) for cancer detection, diagnosis, prognosis, monitoring, and prediction of response in treatment, as well as markers for cancer control and prevention. Research 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 for this NOFO encourage multi-disciplinary 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. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-24-304.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 356680 Full Announcement-PAR-24-304 -> PAR-24-304-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 | PKG00288402 | Jan 14, 2025 | Oct 14, 2026 | View |
Package 1
Mandatory forms
356680 RR_SF424_5_0-5.0.pdf
356680 PHS398_CoverPageSupplement_5_0-5.0.pdf
356680 RR_OtherProjectInfo_1_4-1.4.pdf
356680 PerformanceSite_4_0-4.0.pdf
356680 RR_KeyPersonExpanded_4_0-4.0.pdf
356680 PHS398_ResearchPlan_5_0-5.0.pdf
356680 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
356680 RR_Budget_3_0-3.0.pdf
356680 RR_SubawardBudget30_3_0-3.0.pdf
356680 PHS398_ModularBudget_1_2-1.2.pdf
356680 PHS_AssignmentRequestForm_4_0-4.0.pdf