Integrating Biospecimen Science Approaches into Clinical Assay Development
NIH supports research to standardize biospecimen handling and reduce preanalytical variability for more reliable clinical cancer biomarker assays.
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Funder: National Institutes of Health
Due Dates: September 10, 2026 | February 4, 2027 | June 4, 2027 | September 10, 2027
Funding Amounts: Up to $250,000 in direct costs per year, max 5 years (U01 cooperative agreement)
Summary: Supports research to address preanalytical biospecimen variability and standardize practices for improved clinical biomarker assay development in cancer.
Key Information: Clinical trial proposals not allowed; multidisciplinary teams and collaboration are strongly encouraged.
Description
This NIH National Cancer Institute (NCI) funding opportunity (PAR-25-325) supports extramural research focused on understanding and mitigating preanalytical variability in biospecimen handling as it impacts the development and validation of clinical biomarker assays for cancer. The cooperative agreement (U01) mechanism is intended for multidisciplinary teams investigating how factors such as collection, processing, and storage of tumor tissue biopsies, blood-based liquid biopsies, and other biospecimens influence the reliability and reproducibility of clinically relevant biomarker assays. The ultimate aim is to generate evidence for standardizing biospecimen practices, thereby expediting the development and validation of assays critical for cancer diagnosis, prognosis, and treatment selection.
Eligible research may include studies on tumor tissue (core biopsies, FNAs, small excisions), blood (cfDNA, CTCs, exosomes), and other biospecimens (urine, saliva, CSF, feces, breast milk, etc.). Projects should focus on clinically relevant emerging or established biomarkers and not on biomarker discovery or technology development.
