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

National Institutes of Health · Opportunity number PAR-25-325

View the official notice on Grants.gov
329 days left (deadline Sep 10, 2027)

Details summarized from the official notice as of Oct 16, 2026. Always confirm eligibility, deadlines and requirements in the official notice before applying.

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Key facts

Opportunity numberPAR-25-325
AgencyNational Institutes of Health
Department of Health and Human Services
Assistance listing (ALN, formerly CFDA)93.393
PostedDec 13, 2024
DeadlineSep 10, 2027
Cost sharing or matching requiredNo
Funding typeCooperative agreement
CategoryEducation
Last updated hereOct 16, 2026

Summary from the notice

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

The official notice lists these applicant types as eligible:

  • Small businesses
  • Private colleges and universities
  • State governments
  • Others named in the notice (see the eligibility text)
  • Other Native American tribal organizations
  • Nonprofits without 501(c)(3) status (other than colleges)
  • Special district governments
  • For-profit organizations other than small businesses
  • Public and Indian housing authorities
  • Public and state colleges and universities
  • Nonprofits with 501(c)(3) status (other than colleges)
  • City or township governments
  • Independent school districts
  • County governments
  • Federally recognized tribal governments

Who should take a closer look

  • Small businesses
  • Nonprofits
  • Colleges and universities
  • State governments
  • Local governments
  • Tribal governments and organizations
  • Larger for-profit companies

Not listed as eligible

  • Individuals

Unless the eligibility text in the notice names you, this opportunity is probably not for you.

Eligibility details from the notice

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.

Registrations you will likely need

Most applications submitted through Grants.gov need the following. Registration can take several weeks, so start early. The notice lists the exact requirements.

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