Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed)
Open Posted
- Opportunity number
- PAR-25-325
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Categories
-
- Education
- Health
- Eligible applicants
-
- Small Businesses
- Higher Education Inst. (Private)
- State Governments
- Other
- Tribal Organizations (Not Federally Recognized)
- Non-501(c)(3) Nonprofits
- Special District Governments
- For Profit Organizations
- Public or Indian Housing Auth.
- Higher Education Inst. (Public)
- 501(c)(3) Nonprofits
- City/Township Governments
- Independent School Districts
- County Governments
- Tribal Governments (Federally Recognized)
- Points of contact
-
- NIH OER Webmaster grantsinfo@nih.gov
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Cancer Institute seeks applicants for extramural research to investigate and mitigate preanalytical variability in biospecimens used for clinical assay development and analytical validation, with applications due September 10, 2027.
This U01 cooperative agreement excludes clinical trials. Eligible applicants span small businesses, higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), state and local governments, tribal organizations (federally and non-federally recognized), for-profit organizations, and special district governments. Other eligible applicants include HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian serving institutions, TCCUs, faith-based and community-based organizations, regional organizations, federal agencies, U.S. territories and possessions, and non-domestic entities.
Investigator-designed experiments will examine how different biospecimen preanalytical conditions—including collection, processing, and storage procedures—affect biomarker quantification across testing platforms. Research scope encompasses tumor tissue biopsies, blood-based liquid biopsies, tissue swabs, tissue secretions, pleural and esophageal aspirates, feces, and bodily fluids including sweat, urine, cerebrospinal fluid, breast milk, and saliva. The program aims to expedite biomarker clinical assay development through evidence-based standardization of biopsy handling practices and improved understanding of how analytical quantification of clinically relevant biomarkers is affected by preanalytical variation.
Funding falls under Cancer Cause and Prevention Research (CFDA 93.393). Review criteria include scientific merit and significance of proposed objectives, technical adequacy of experimental design, investigator competency, facility and resource adequacy, budget necessity relative to project scope, and relevance to program objectives. Evaluation will be conducted by scientific peer review and the National Cancer Advisory Board.
Synopsis
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.
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.
Files
| File | Type | Posted |
|---|---|---|
| PAR-25-325-Full-Announcement.html | HTML file | |
| PKG00289623.pdf |
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