Development of devices, diagnostic technologies, or digital health tools for treatment, detection, and diagnosis of Pediatric Cancers and/or Rare Cancers.

About 9,550 children in the United States under the age of 15 will be diagnosed with cancer in 2025 (https://www.cancer.org/cancer/cancer-in-children/key-statistics.html). Cancer is the leading cause of death from disease in children ages 1 to 14 in the US after infancy. Similarly, as a group, rare cancers are the leading cause of cancer deaths in the United States (https://rarecancer.org/). For the purposes of this solicitation, a rare cancer is defined in accordance with the U.S. Food and Drug Administration (FDA) Orphan Drug Act as a malignancy with a total U.S. prevalence of fewer than 200,000 individuals. Prevalence estimates should be supported by authoritative data sources (e.g., SEER) or where direct estimates are not available, by scientifically justified epidemiologic approximations based on published literature. This definition is intended to capture clinically and biologically relevant rare cancer populations that may not be fully represented in existing rare disease databases. Applications must clearly describe how the proposed technological approach has the potential to result in a meaningful improvement in patient survival and/or to address areas of significant unmet medical need where the current standard of care has demonstrated limited progress. Access the NCI Surveillance, Epidemiology, and End Results Program (SEER) database (https://seer.cancer.gov/) for more information regarding 5-year cancer survival rates. Because of smaller patient populations and challenging development pathways, development of new technologies focused on pediatric and rare cancers lag significantly compared to other major cancers. Innovative and transformative solutions focused on prevention, diagnosis, detection, and treatment in both pediatric cancers and rare cancers are urgently needed. Rather than just the tried and tested approaches that have not led to much success and progress, bold and “out of the box” ideas that are still based on sound scientific premise are needed to make a significant impact in the prevention, diagnosis, treatment, and care of patients with pediatric and/or rare cancer. Thus, the NCI SBIR Development Center has developed the NCI SBIR Innovative Concept Award program to encourage the development of high-risk innovative and disruptive technologies. The Concept Award program will provide funding to small businesses to explore the technical feasibility and demonstrate proof of concept for the development of highly innovative therapies, devices, diagnostic tools, or preventive strategies focused on pediatric and rare cancers. The focus is on innovation and “out of the box” ideas that have not been tried and tested before. So, preliminary data is not required; however, proposed ideas should have sound scientific premise either based on the offeror’s own research or referenced literature evidence. Offerors are eligible to apply if they have disruptive ideas based on sound scientific premise with a potential to make an impact in these cancers. The goal of the funding is for offerors to generate de-risking technical data that provides key proof of concept validation. We also want the offerors to explore the commercial potential and development path of the technology during the award period. In addition to funding, the program will also provide additional business and commercialization resources including entrepreneurship training to explore and refine the business model and commercialization plan. Activities and deliverables proposed by the offerors would differ based on their technology types and stage of development. However, the offerors should ensure that they clearly identify the clinical problem and cancer type(s) that the proposal will focus on with adequate justification. In addition, the offerors should propose experiments to obtain initial de-risking and proof-of-concept data and at the completion of the project present a report with the results of the experiments to the NCI. Examples of activities and deliverables that could be proposed include (but are not limited to) the following: Device Development Projects: The offeror could propose most or all of these activities for pediatric or rare cancers. • Evaluation and justification of clinical need • Product concept and protype development • Early feasibility studies • Phantom validation • In vivo validation studies • Software development (if needed) • Biocompatibility, sterility, and safety studies Diagnostics Development Projects: The offeror could propose most or all of these activities for pediatric or rare cancers. • Biomarker optimization and qualification • Assay development and optimization • Define assay performance and analytic validation • Sensitivity, specificity, and reproducibility • Validation studies in deidentified clinical samples