OpenFederal grantOpen to for-profit businessesPAR-25-325

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

National Institutes of HealthCloses Sep 10, 2027(332 days left)

Does this fit your business?

This is an NIH/NCI research grant (U01) for studying how biopsy and biospecimen handling affects cancer biomarker test development and validation. It is for research teams in healthcare, biotech, and academia, not for general small-business needs. If you are not doing laboratory research on clinical assays or biospecimens, do not bother applying.

Best for
Biotech and diagnostics companies developing cancer biomarker assays, Universities and cancer research labs, Hospitals and clinical research organizations, Nonprofits and government labs doing biospecimen research
Not for
Retail, construction, transportation, and other businesses outside biotech or clinical research, Organizations looking for funding to run clinical trials, Applicants seeking general business or operating capital
Estimated fit by industry, best first
IndustryEstimated fit
Healthcare & BiotechMatches your industry (clinical)
73
Good Match
Arts & CultureLimit: Not clearly about your industry or what you need funding for; check the…
54
Possible Match
Education & TrainingLimit: Not clearly about your industry or what you need funding for; check the…
54
Possible Match
Energy & Clean TechLimit: Nothing in this notice points to energy & clean tech
54
Possible Match
Environment & ConservationLimit: Nothing in this notice points to environment & conservation
54
Possible Match
Food & BeverageLimit: Nothing in this notice points to food & beverage
54
Possible Match
Show all 15 industries
Estimated fit by industry, best first
IndustryEstimated fit
Housing & Real EstateLimit: Nothing in this notice points to housing & real estate
54
Possible Match
Social Services & NonprofitLimit: Not clearly about your industry or what you need funding for; check the…
54
Possible Match
Technology & SoftwareLimit: Nothing in this notice points to technology & software
54
Possible Match
Finance & BankingLimit: Nothing in this notice points to finance & banking
53
Possible Match
Agriculture & FarmingLimit: Nothing in this notice points to agriculture & farming
51
Possible Match
ManufacturingLimit: Nothing in this notice points to manufacturing
51
Possible Match
Construction & InfrastructureLimit: Nothing in this notice points to construction & infrastructure
49
Possible Match
Retail & E-CommerceLimit: Nothing in this notice points to retail & e-commerce
49
Possible Match
Transportation & LogisticsLimit: Nothing in this notice points to transportation & logistics
49
Possible Match

These are our matcher’s estimates for a typical business in each industry. A real match depends on your size, your state and what you need the money for — check your own fit.

What this funds

Money can be used for
Research
Who can apply
Small businesses, For-profit companies, Nonprofits, State and local governments, Tribal governments and organizations, Colleges and universities, Other applicants (see eligibility)

Questions about this grant

When is the application deadline?
September 10, 2027.
Who can apply for this grant?
Small businesses, for-profit companies, nonprofits (with or without 501(c)(3) status), universities, state/local/tribal governments, public housing authorities, independent school districts, and certain other entities such as foreign organizations and faith-based or community-based organizations can apply.
Can a sole proprietor or single-member LLC apply?
The facts do not say. Small businesses are eligible, but the notice does not specify whether sole proprietors or single-member LLCs qualify as small businesses for this program.
Can a nonprofit apply?
Yes. Nonprofits with or without 501(c)(3) IRS status (other than institutions of higher education) are listed as eligible applicants.

Summary

NIH/NCI U01 research grants to study how preanalytical variability in tumor biopsies, blood-based liquid biopsies, and other biospecimens affects clinical biomarker assay development and validation. Open to small businesses, for-profits, universities, nonprofits, governments, tribes, and other eligible entities; no clinical trials.

About this grant

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

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.

Topics and uses of funds

Topics

  • Health
  • Science
  • Research

Program contact

National Institutes of Healthgrantsinfo@nih.gov301-402-2541

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