§ Federal grant opportunity · PAR-25-325

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

    National Institutes of Health is accepting applications for Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed). The deadline is September 10, 2027 and the published award range is Award amount not published.

    Key facts

    Funder
    National Institutes of Health
    Application deadline
    September 10, 2027
    Award range
    Award amount not published
    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.
    Geography
    United States
    Focus areas
    Education, Health
    Opportunity number
    PAR-25-325

    Program overview

    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.

    How to apply

    1. Confirm your organization meets the eligibility criteria above.
    2. Read the full funding opportunity announcement from National Institutes of Health.
    3. Draft your narrative against the funder's stated priorities and review criteria.
    4. Submit before September 10, 2027, allowing time for registration and validation.

    View the official funding announcement

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