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Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)

List of required information for application:

1. Assay validation plan: Provide a detailed plan for validating the molecular/cellular/imaging markers and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control.

2. Importance and justification: Clearly explain the importance and justification for developing the assays into clinical assays for cancer treatment, control, or prevention trials.

3. Assays for human samples: Specify that the assays are designed to work on human samples.

4. Multi-marker assays: If applicable, describe the assays for measuring multiple markers, including immune markers, that can be developed and validated simultaneously.

5. UH2 phase: Outline the plan for achieving analytical validation of the assays within 2 years.

6. UH3 phase: Describe the plan for conducting clinical validation of the analytically validated assays for up to 3 years using well-annotated biospecimens from retrospective or prospective clinical trials or studies.

7. Validation of existing assays: Explain if the proposed project aims to validate existing assays for use in other cancer clinical trials, observational studies, or population studies.

8. Harmonization of clinical laboratory tests: If applicable, describe the efforts to harmonize clinical laboratory tests, including investigating the performance and reproducibility of assays across multiple clinical laboratories.

9. Collaboration: Highlight the multi-disciplinary collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists that will be required for the project.

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88%

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93%

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