The National Institutes of Health (NIH) is inviting small businesses to submit proposals for the development of innovative devices, diagnostic technologies, or digital health tools aimed at the treatment, detection, and diagnosis of pediatric and rare cancers. The solicitation encourages "out of the box" ideas that demonstrate proof of concept for transformative technologies, emphasizing that projects should not merely optimize existing solutions but rather introduce novel approaches that could significantly enhance cancer care. This initiative is part of the SBIR Phase I program, with applications due by October 17, 2025, and aims to support high-risk, high-reward projects that may lead to groundbreaking advancements in cancer management. Interested parties can find more details and submit proposals through the official NIH SBIR website.

The goal of this solicitation is to encourage small businesses to propose “out of the box” ideas to demonstrate “proof of concept” for the development of innovative technologies to make a transformative impact in prevention, diagnosis, treatment, and care of pediatric or rare cancer patients. To be considered innovative, projects must have the potential to transform the way research is conducted through the development of novel tools or technologies or lead to major improvements in pediatric and rare cancer care through the development of highly innovative therapies, diagnostic tools, or preventive strategies. Projects that primarily focus on optimization, hardening, or obvious extrapolations of established technology might be less competitive. For example, the following types of projects would not be considered innovative and would not be responsive:
• Therapeutics targeting genes and pathways with FDA-approved agents or agents in late clinical stage unless the novel approach mitigates known issues with approved agents
• Screening, diagnostic, and monitoring approaches already in clinical use
• Continuation of already funded SBIR/STTR projects
Proposals are encouraged for the development of innovative approaches focused on detection, prevention, and treatment of pediatric or rare cancers. The solicitation is agnostic to the type of technologies and modalities as long as they are highly innovative and reflect ideas substantially improved from current state of the art. Projects supported by this program should not be low risk, or incremental improvements to established technologies. These could include but not limited to novel therapeutics and prevention approaches, therapeutic devices, drug delivery approaches, and devices focused on early diagnosis, prognosis, and treatment response.
Proposals are solicited for all innovative ideas – not limited to the ones above – if they are focused on detection, prevention, and treatment of pediatric cancers or rare cancers. Projects are anticipated to have a high risk of failure with concomitant high reward. Commercial potential is evaluated by assuming the continued development of technology is successful, regardless of the inherent risk of the project.
The awards will support initial exploration of untested but potentially transformative ideas that may radically change the way we understand, prevent, diagnose, treat, and manage rare or pediatric cancers. These Concept Awards are intended to provide funds to perform key de-risking activities to demonstrate proof-of-concept and feasibility and lay the groundwork for future Federal funding opportunities. Concept awards are not intended to support continuation of already established and advanced research programs. Thus, preliminary data is not required; however, the ideas should have sound scientific premise either based on the offeror’s own research or literature evidence. These awards are focused on development of innovative products and technologies; thus, the anticipated product that will be developed should be identified and a development path should be clearly laid out.
In addition to funds provided to demonstrate technical proof-of-concept, the program will integrate customer discovery and entrepreneurial training to ensure that awardees develop an appropriate business model, market fit, and commercialization plan. As such, the awardees are expected to go through the NIH I-CorpsTM (see section 2.3) program. Concept Awardees will also receive entrepreneurial mentorship to help them refine their 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

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

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