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Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed)

Federal funding opportunity PAR-25-325 from National Institutes of Health (Department of Health and Human Services).

Apply on Grants.gov →Application closes September 10, 2027

Posted: December 13, 2024
Closes: September 10, 2027
Cost sharing: No
Instrument: Cooperative Agreement
Assistance listing: 93.393
Category: Education, Health
Archives: October 16, 2027

Program funding history

Awards made under Assistance Listing 93.393 across FY2024–FY2026, from public federal spending records.

FY2024 obligated: $730.8M
FY2025 obligated: $803.1M
FY2026 (to date) obligated: $471.3M
Awards in window: 2,980

Top recipients: The Univeristy of Texas M.d. Anderson Cancer Center, Dana-farber Cancer Institute, Inc., Sloan-kettering Institute for Cancer Research, University of North Carolina at Chapel Hill, The Trustees of Columbia University in the City of New York

Source: USAspending.gov · refreshed August 2026

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.

Who can apply

For profit organizations other than small businesses
Others (see text field entitled "Additional Information on Eligibility" for clarification)
County governments
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
City or township governments
Private institutions of higher education
Public and State controlled institutions of higher education
State governments
Native American tribal governments (Federally recognized)
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Small businesses
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education

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.

How to apply

Applications go through the official government listing. Grants Radar links you straight to the source — applying is free.

View on Grants.gov Full announcement

Agency contact: National Institutes of Health · [email protected] · 301-402-2541

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