Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed)
National Institutes of Health (NIH)
Up to $250,000 direct costs per year
Maximum project period of 5 years
Support extramural research to investigate and mitigate challenges in clinical assay development due to preanalytical variability in biospecimens.
Researchers in biospecimen science and clinical assay development
Healthcare providers involved in cancer diagnostics
Patients benefiting from improved diagnostic accuracy
Eligible organization types include higher education institutions, nonprofits, for-profit organizations, small businesses, local governments, state governments, and tribal governments.
Non-domestic (non-U.S.) entities are also eligible to apply.
Open to U.S. and non-domestic entities.
Research must focus on preanalytical variability in biospecimens such as tumor biopsies and liquid biopsies.
Projects should aim to improve clinical assay development and validation.
Application budgets are limited to $250,000 direct costs per year.
Applications are due by September 10, 2027.
Earliest submission date is January 4, 2025.
No specific restrictions on prior grant funding mentioned.
Follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide.
Applications will be evaluated based on significance, innovation, rigor, and feasibility.
Applications will undergo scientific peer review and will be evaluated for scientific and technical merit.
Potential to improve reliability of clinically relevant biomarker assays.
Research must not propose clinical trials.
Applications must address specific preanalytical factors affecting biomarker assays.
Collaboration among multidisciplinary teams is essential.
Ensure compliance with application instructions to avoid delays.