Simpler Grants.gov #PAR-28-042

NCI funding for validation of cancer biomarkers and assays

The National Cancer Institute is seeking research applications to validate cancer biomarkers and assays using human samples. - Government buyer: U.S. Department of Health and Human Services, National Institutes of Health (NIH), through the National Cancer Institute (NCI). - Opportunity: Research funding under PAR-28-042 for analytical and clinical validation of molecular, cellular, and in vitro imaging biomarkers and assays for cancer-related needs, including detection, diagnosis, prognosis, monitoring, treatment response or resistance, prevention and control, pharmacodynamic markers, and toxicity markers. - Funding mechanisms: Applicants may propose a phased UH2/UH3 cooperative agreement or a standalone UH3 project. Clinical trials are not allowed. - UH2 may request up to $275,000 in direct costs total, with no more than $200,000 in any one year. - UH3 may request up to $250,000 in direct costs per year. - For phased projects, quantitative analytical and clinical validation milestones guide transition to UH3. - Notable requirements: Proposals must address a defined cancer-related clinical need and specify the assay’s intended use. Existing assays should have been reduced to practice in human tissues. Validation should follow applicable laboratory standards, such as CLIA or GLP/ISO 17025. - Eligibility: Qualifying U.S. institutions, governments, businesses, nonprofits, and other listed organizations may apply. Foreign organizations and non-domestic components of U.S. organizations are ineligible, although permitted foreign components may participate. - OEMs, vendors, products, and quantities: None are specified; this is a research funding opportunity rather than a procurement of commercial products or services.

Description

This funding opportunity supports analytical and clinical validation of molecular, cellular, and imaging biomarkers and assays for cancer-related clinical needs. It covers markers for cancer detection, diagnosis, prognosis, monitoring, treatment response or resistance, prevention and control, pharmacodynamic effects, and toxicity. Funding uses either a phased UH2/UH3 or a standalone UH3 cooperative agreement mechanism to support laboratory optimization and validation of assays using human samples. Applicants must define the intended use, and non-U.S. entities and non-domestic components of U.S. organizations are ineligible.

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