The National Cancer Institute (NCI) is offering this grant to support extramural research aimed at overcoming challenges in clinical assay development. This grant is for investigating how preanalytical variability in biospecimens, such as tumor tissue biopsies, blood (liquid biopsies), and other bodily fluids, impacts emerging biomarker quantification. Investigator-designed experiments will explore the effects of different biospecimen collection, processing, and storage conditions on various testing platforms. The overall goal is to improve the understanding of how analytical quantification of clinically relevant biomarkers is affected by these critical preanalytical factors. By generating evidence-based knowledge, this program seeks to expedite biomarker clinical assay development through the standardization of biopsy and biospecimen handling practices, ultimately enhancing assay reliability.
Opportunity ID: 357712
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-325 |
| Funding Opportunity Title: | Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 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: | 93.393 — Cancer Cause and Prevention Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Dec 13, 2024 |
| Last Updated Date: | Dec 13, 2024 |
| Original Closing Date for Applications: | Sep 10, 2027 |
| Current Closing Date for Applications: | Sep 10, 2027 |
| Archive Date: | Oct 16, 2027 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Small businesses Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than 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 City or township governments County governments For profit organizations other than small businesses |
| 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), the National Cancer Institute (NCI) intends to support extramural research to investigate and mitigate challenges facing clinical assay development and subsequent analytical validation due to preanalytical variability in tumor tissue biopsies, blood biospecimens utilized as liquid biopsies”, or other biospecimens as described in this NOFO. Extramural research funded under this NOFO may include investigations of preanalytical variability associated with the procurement and study of small biopsies (core biopsies, small excision samples), blood utilized for “liquid biopsies”, tissue swabs, tissue secretions, pleural and esophageal aspirates, feces, or bodily fluids like sweat, urine, CSF, breast milk and saliva. Investigator-designed experiments will explore how different biospecimen preanalytical conditions affect emerging and clinically relevant biomarkers quantified by a variety of testing platforms. The results from this research program will improve the understanding of how analytical quantification of clinically relevant biomarkers is affected by variation in biospecimen collection, processing, and storage procedures. The overall goal is to expedite biomarker clinical assay development through evidence-based standardization of biopsy handling practices. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-325.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 357712 Full Announcement-PAR-25-325 -> PAR-25-325-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 | PKG00289623 | Jan 04, 2025 | Sep 10, 2027 | View |
Package 1
Mandatory forms
357712 RR_SF424_5_0-5.0.pdf
357712 PHS398_CoverPageSupplement_5_0-5.0.pdf
357712 RR_OtherProjectInfo_1_4-1.4.pdf
357712 PerformanceSite_4_0-4.0.pdf
357712 RR_KeyPersonExpanded_4_0-4.0.pdf
357712 PHS398_ResearchPlan_5_0-5.0.pdf
357712 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357712 RR_Budget_3_0-3.0.pdf
357712 RR_SubawardBudget30_3_0-3.0.pdf
357712 PHS398_ModularBudget_1_2-1.2.pdf
357712 PHS_AssignmentRequestForm_4_0-4.0.pdf
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