Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed) PAR-26-091

The National Cancer Institute (NCI), a component of the U.S. Department of Health and Human Services under the National Institutes of Health (NIH), has released a forecasted Notice of Funding Opportunity (NOFO) titled "Assay Validation of High Quality Markers for Clinical Studies in Cancer." This program aims to facilitate the validation of molecular, cellular, and imaging biomarkers critical to advancing cancer diagnostics, prognostics, therapeutic decision-making, and preventive measures. The funding mechanism supports both a biphasic UH2/UH3 model and a monophasic UH3 model to enable the transition of assays from analytical to clinical validation phases. Under the biphasic UH2/UH3 model, applicants will receive support for up to five years. The UH2 phase focuses on analytical validation over two years, after which successful projects may transition to the UH3 clinical validation phase for up to three additional years. Applicants must propose clear milestones for the UH2 phase to ensure eligibility for transition. In contrast, the monophasic UH3 mechanism provides three years of funding strictly for clinical validation, contingent on prior analytical validation of the assays. Assays must target human samples and be justified for use in clinical settings, such as retrospective or prospective clinical trials. This funding opportunity encourages applications that support the development of assays for pharmacodynamic markers, markers of toxicity, and immune markers, especially in the context of combined therapeutic approaches like immunotherapy with chemotherapy or radiation. The assays should be suitable for deployment in clinical laboratories and support improved cancer prevention, monitoring, treatment, or control. Projects may also involve harmonization and reproducibility testing of assays across multiple clinical laboratories, supporting the broader goal of standardizing cancer biomarker assessments. Eligibility is expansive and inclusive of a wide array of public, private, nonprofit, and tribal entities. Applicants can include small businesses, higher education institutions, nonprofit organizations, state and local governments, housing authorities, and tribal organizations, among others. The NOFO encourages multidisciplinary collaboration among oncologists, statisticians, laboratory scientists, and clinical researchers to ensure the effective translation of validated assays into clinical settings. The estimated post date for this NOFO is February 16, 2026, with applications due by February 8, 2027. Awards are projected to be announced by December 1, 2027, which is also the estimated project start date. The NOFO is classified as a discretionary funding opportunity under CFDA 93.394 for Cancer Detection and Diagnosis Research. No cost sharing or matching funds are required. Applicants or institutions seeking further information can contact the Cancer Diagnosis Program at 240-276-5748 or via email at NCICDPNOFO@mail.nih.gov. Interested entities are encouraged to prepare for submission well in advance of the due date and to monitor Grants.gov for the official release of the full NOFO and application materials.