Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed)
This grant supports research on improving clinical assay development by addressing variability in biospecimen collection procedures, aiming to expedite biomarker validation.
Funder: National Institutes of Health
Due Dates: June 4, 2025 | September 10, 2025 | February 4, 2026 | June 4, 2026 | September 10, 2026 | February 4, 2027 | June 4, 2027 | September 10, 2027
Funding Amounts: Up to $250,000 direct costs per year, for a maximum project period of 5 years (U01 cooperative agreement mechanism).
Summary: Supports research to address preanalytical variability in biospecimen collection and handling to improve the development and validation of clinical biomarker assays.
Key Information: Clinical trials are not allowed; applications must focus on assay development/validation, not biomarker discovery or technology development.
Description
This opportunity, offered by the National Cancer Institute (NCI) at NIH, funds extramural research to investigate and mitigate challenges in clinical assay development and analytical validation caused by preanalytical variability in biospecimen collection, processing, and storage. The program aims to generate evidence-based standards for handling tumor tissue biopsies, blood (liquid biopsies), and other biospecimens (e.g., tissue swabs, secretions, pleural/esophageal aspirates, feces, sweat, urine, CSF, breast milk, saliva) to improve the reliability and reproducibility of clinically relevant biomarker assays.
The overarching goal is to expedite the development and implementation of biomarker assays in clinical settings, particularly for cancer research and clinical trials, by reducing variability and bias introduced during biospecimen handling.
