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NIH Research Project Cooperative Agreement (U01)

Integrating Biospecimen Science Approaches into Clinical Assay Development

Funds research into how preanalytical handling of biopsies and other biospecimens distorts biomarker results used in clinical assays.

A biomarker test is only as good as the biopsy or fluid sample that produced it. This notice funds finding out how much handling, before any analysis starts, quietly changes the answer.

The problem is named precisely: preanalytical variability in tumour tissue biopsies, blood used for liquid biopsies, or other biospecimens, and what that variability does to clinical assay development and its anal

Investigator-designed research into how preanalytical variability — collection, processing and storage — in tumour tissue biopsies, liquid biopsies, tissue swabs, secretions, aspirates, faeces or bodily fluids affects biomarkers measured by existing clinical assay platforms, aimed at evidence-based standardisation of biospecimen handling. Clinical trials are not allowed.

CycleiHow often this grant runs — e.g. annually, on a rolling basis, or a one-off call.Multiple per year
Next deadlineiThe next date applications are due. Rolling means you can apply any time.10 Sept 2027
Decision timeiTypical time from the deadline to the funder's decision.26 weeks
Project durationiHow long the funded work is expected to run.
Award typeiThe form of funding — grant, equity, loan, tax credit, etc.Cooperative agreement
Match fundingiThe share of project costs you must cover yourself. 0% = fully funded.
Funding pooliThe total budget available across all awards in this round.

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Last verified: 25 Aug 2026Funder reference: PAR-25-325Source: www.grants.gov