Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)

The National Cancer Institute (NCI) announces a grant opportunity with the focus being on advancing the acceptance and confirmation of molecular, cellular, and imaging markers. These biomarkers are key in diagnosing, detecting, and monitoring cancer, determining prognosis, and predicting responses or resistance to treatments. The grant also emphasizes the importance of markers in cancer control and prevention and will support the confirmation of pharmacodynamic markers and markers of toxicity.

The grant is open to applicants that have already validated the performance of their assays in specimens that are similar to those in the intended clinical use. This implies a focus on existing, tested technology rather than early-stage development. The initiative encourages simultaneous development and validation of assays to measure multiple markers, including those related to immune responses. This is noteworthy as immunotherapies increasingly work in tandem with chemotherapies and radiation therapies to enhance long-term anti-cancer responses.

Funded under the UH3 mechanism, the grant aims to support the clinical validation of established assays for up to three years. This process of validation will utilize specimens from either retrospective or prospective clinical trials or studies. The grant can also be used for the validation of existing assays intended for use in other trials, observational studies, or population studies.

Additionally, projects aimed at unifying clinical laboratory tests will be eligible for funding. These include studies into the performance and reproducibility of assays across various clinical laboratories.

Applying for this grant requires a collaborative approach, bringing together multiple disciplines, including scientific investigators, oncologists, statisticians, and clinical laboratory scientists. The ultimate objective of this grant is to validate assays to the point of being able to incorporate them into clinical trials or studies as investigational assays.