This National Cancer Institute (NCI) grant aims to accelerate the translation of NCI-supported methods and technologies into clinical use. Specifically, this funding opportunity focuses on the adaptation and clinical validation of molecular, cellular, and imaging biomarkers. These biomarkers are intended for critical applications such as cancer detection, diagnosis, prognosis, monitoring treatment response, and supporting cancer control and prevention efforts. Successful projects may involve acquiring well-annotated specimens from existing clinical trials or observational cohorts for assay validation. The grant encourages multidisciplinary collaboration among scientists, assay developers, clinicians, and statisticians, with strong encouragement for clinical laboratory and statistical experts. This initiative supports validating assays for integration into clinical trials as investigational tools, not early-stage development or direct clinical trials.
Opportunity ID: 345268
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-23-088 |
| 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: | Jan 06, 2023 |
| Last Updated Date: | Jan 06, 2023 |
| Original Closing Date for Applications: | Oct 27, 2023 |
| Current Closing Date for Applications: | Oct 27, 2023 |
| Archive Date: | Dec 02, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $150,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts State governments Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) For profit organizations other than small businesses Special district governments Native American tribal organizations (other than Federally recognized tribal governments) County governments Native American tribal governments (Federally recognized) City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public and State controlled institutions of higher education Private 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Funding Opportunity Announcement (FOA) 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 FOA 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 FOA 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 FOA 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-23-088.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
There are no related documents on this grant.
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-H | Use for due dates on or after January 25, 2023 | PKG00279130 | Jan 28, 2023 | Oct 27, 2023 | View |
Package 1
Mandatory forms
345268 RR_SF424_5_0-5.0.pdf
345268 PHS398_CoverPageSupplement_5_0-5.0.pdf
345268 RR_OtherProjectInfo_1_4-1.4.pdf
345268 PerformanceSite_4_0-4.0.pdf
345268 RR_KeyPersonExpanded_4_0-4.0.pdf
345268 PHS398_ResearchPlan_5_0-5.0.pdf
345268 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
345268 RR_Budget_3_0-3.0.pdf
345268 RR_SubawardBudget30_3_0-3.0.pdf
345268 PHS398_ModularBudget_1_2-1.2.pdf
345268 PHS_AssignmentRequestForm_3_0-3.0.pdf
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