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Simpler Grants

No. PAR-25-325 · National Institutes of Health

Open

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

grants.gov listing Full announcement (NOFO)
Dealbreakers No cost share required Audit: not stated
Not reimbursement-only
“Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement.” — From the announcement
Award range
Not specified
Expected awards
Not specified
Application deadline
Sep 10, 2027
Posted
Dec 13, 2024
Last verified
7 days ago

At a glance

AI summary

This NOFO funds extramural research on how preanalytical differences in biospecimen collection, processing, storage, and handling affect clinical biomarker assay development and validation. It focuses on small tumor biopsies, blood used for liquid biopsies, and other specimen types such as swabs, secretions, aspirates, feces, sweat, urine, CSF, breast milk, BAL, and saliva. Applicants may include nonprofits, universities, for-profits, governments, faith-based or community-based organizations, and foreign organizations or foreign components of U.S. organizations. Awards use a cooperative agreement mechanism, with direct costs limited to $250,000 per year, a maximum project period of 5 years, and the number of awards depending on NIH appropriations and meritorious applications. Clinical trials are not allowed, and the announcement says it does not support biomarker discovery or early detection biomarker projects.

AI-generated summary — verify against the announcement

What it funds

  • Education
  • Health
  • Research & Discovery
  • Researchers & Scholars
  • Biomedical & Disease Research
Official description from grants.gov

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

  • City or township governments
  • County governments
  • For-profit organizations other than small businesses
  • Independent school districts
  • Native American tribal governments (Federally recognized)
  • Native American tribal organizations (other than Federally recognized)
  • Nonprofits with 501(c)(3) status (other than higher education)
  • Nonprofits without 501(c)(3) status (other than higher education)
  • Others
  • Private institutions of higher education
  • Public and State controlled institutions of higher education
  • Public housing authorities / Indian housing authorities
  • Small businesses
  • Special district governments
  • State governments
Geographic restriction None found in the announcement — likely nationwide

Program history

USASpending.gov

Assistance listing 93.393 · Cancer Cause and Prevention Research

Real awards this federal program has made — the whole assistance listing (93.393), not just this notice.

Fiscal year Awards Median award Middle half
FY 2026 (so far) 167 $596,996 $422,899 – $685,984
FY 2025 233 $743,438 $397,772 – $1,287,560
FY 2024 331 $1,232,605 $403,858 – $1,928,145
FY 2023 333 $1,580,141 $399,888 – $2,324,497
FY 2022 371 — —
FY 2021 317 — —

Dollar figures are based on the 1,000 most recent awards we store, not all 1,752 — award counts are complete.

Who wins it Higher education (1,176), Nonprofit (458), Business (49) of 1,752 awards — categories can overlap.
Top states NY (124) · CA (100) · MA (89) · TX (82) · NC (34)
Largest recent awards
  1. HEALTH RESEARCH, INC. $8,975,418 · FY 2023
  2. REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE $7,529,016 · FY 2024
  3. WAKE FOREST UNIVERSITY HEALTH SCIENCES $7,411,948 · FY 2023
  4. VANDERBILT UNIVERSITY MEDICAL CENTER $7,120,874 · FY 2023
  5. REGENTS OF THE UNIVERSITY OF MINNESOTA $6,827,635 · FY 2023

Source: USASpending.gov · refreshed Aug 14, 2026