Simpler Grants.gov #360946

Cancer Biomarker and Assay Validation for Clinical Studies

The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), is seeking applications for the validation of cancer biomarkers and assays to improve cancer detection, diagnosis, prognosis, and treatment monitoring. - Government Buyer: - National Institutes of Health (NIH) - National Cancer Institute (NCI) - Products/Services Requested: - Analytical and clinical validation of molecular, cellular, and imaging biomarkers and assays - Assays for pharmacodynamic, toxicity, and immune markers - Use of well-annotated human biospecimens from clinical studies or trials - Application Structure: - Biphasic UH2/UH3 (Developmental Phase I and II) or standalone UH3 (Phase II only) - UH2 phase: Analytical validation (up to 2 years) - UH3 phase: Clinical validation (up to 3 years) - Unique/Notable Requirements: - Harmonization of clinical laboratory tests - Multidisciplinary collaboration among scientific investigators, oncologists, statisticians, and laboratory scientists - Focus on research and assay development; no specific OEMs or commercial products required - No specific OEMs or vendors are named, as the opportunity centers on research and development rather than procurement of commercial products.

Description

The National Cancer Institute (NCI) is soliciting applications to support the validation of molecular, cellular, and imaging markers and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of treatment response or resistance. Applicants may submit either a biphasic UH2/UH3 application for 5 years or a standalone UH3 application for 3 years to support clinical validation of established assays. The UH2 phase supports analytical validation within 2 years, and the UH3 phase supports clinical validation for up to 3 years using well-annotated biospecimens. The opportunity includes validation of pharmacodynamic and toxicity markers, development of immune marker assays, harmonization of clinical lab tests, and requires multidisciplinary collaboration.

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