NIH Highlighted Topic: Research on Rare Cancers Across the Cancer Control Continuum
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
The National Institutes of Health (NIH) is encouraging innovative research proposals focused on advancing prevention, diagnosis, treatment, survivorship, symptom management, and healthcare delivery for rare cancers across the cancer control continuum. This highlighted topic supports multidisciplinary research designed to improve outcomes, reduce disparities, and address major knowledge gaps affecting patients diagnosed with rare cancers.
NIH defines a rare cancer as one with an incidence rate of fewer than 15 cases per 100,000 individuals annually. Although individually uncommon, rare cancers collectively account for approximately 25% of all adult cancer diagnoses and all pediatric cancers in the United States. NIH is particularly interested in projects addressing the unique challenges associated with rare cancers, including delayed diagnosis, limited treatment options, fragmented care delivery, insufficient survivorship research, and disparities in patient outcomes.
Companies developing oncology diagnostics, AI-enabled cancer detection tools, digital health platforms, survivorship technologies, patient monitoring systems, healthcare analytics platforms, clinical decision support software, symptom management solutions, precision medicine tools, or population health technologies may be strong candidates for funding.
Areas of interest include cancer surveillance, behavioral and psychosocial research, healthcare delivery optimization, implementation science, translational prevention research, symptom management interventions, survivorship support, precision prevention, and population-level cancer outcome studies. NIH is also encouraging scalable technologies and evidence-based interventions that improve quality of life and long-term outcomes for patients with rare cancers.
Funding is available through the NIH SBIR/STTR Program, which currently provides up to approximately $323,090 for Phase I projects and up to $2,153,927 for Phase II projects, with opportunities for additional commercialization and follow-on funding depending on the project’s impact and translational potential.
This highlighted topic is supported primarily by the National Cancer Institute (NCI) and the National Institute of Dental and Craniofacial Research (NIDCR), both of which are seeking innovative solutions that improve rare cancer prevention, detection, treatment, survivorship, and healthcare delivery.
How much funding would I receive?
Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.
What could I use the funding for?
Funding may support the research, development, validation, and commercialization of technologies, diagnostics, digital health platforms, analytics systems, and care solutions related to rare cancers.
Eligible activities may include:
AI and machine learning platforms for rare cancer diagnosis and detection
Precision oncology and biomarker discovery technologies
Cancer surveillance and population health analytics systems
Digital health platforms for survivorship and symptom management
Patient monitoring and remote care coordination technologies
Clinical decision support systems for oncology care
Behavioral health and psychosocial support tools for cancer patients
Precision prevention and early detection technologies
Healthcare delivery optimization and interoperability platforms
Real-world evidence and longitudinal cancer outcomes research tools
Patient-reported outcome monitoring systems
Translational and implementation science technologies
Oncology workflow and care navigation platforms
Symptom management interventions and supportive care technologies
Rare cancer registry and data integration systems
Community-based and home-based oncology support platforms
Prototype development, pilot studies, and validation research
Commercialization planning, regulatory preparation, and scale-up activities
Funding may also support personnel, software development, cloud infrastructure, clinical data analysis, healthcare analytics, AI model development, implementation research, patient engagement studies, intellectual property protection, regulatory strategy, and commercialization activities necessary to advance a scalable and commercially viable healthcare or oncology technology solution aligned with NIH priorities.
Are there any additional benefits I would receive?
Beyond the formal funding award, awardees gain several strategic advantages:
Government Validation and Credibility:
Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.Enhanced Visibility and Market Recognition:
Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.Access to the Federal Innovation Ecosystem:
Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.Stronger Commercial and Exit Potential:
By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.
What is the timeline to apply and when would I receive funding?
Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.
Where does this funding come from?
Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.
Who is eligible to apply?
Applicants must be U.S. small business concerns (SBCs) that:
Are organized for profit with a U.S. place of business.
Have ≤ 500 employees including affiliates.
Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.
What companies and projects are likely to win?
Projects that demonstrate:
A clear unmet medical or public-health need,
Strong scientific rationale and feasibility,
High commercialization potential, supported by a realistic market and regulatory strategy, and
Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).
Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.
Are there any restrictions I should know about?
Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.
Foreign entities are not eligible.
Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.
How long will it take me to prepare an application?
For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.
How can BW&CO help?
Our team specializes in complex federal R&D proposals and can:
Triple your likelihood of success through proven strategy and insider-aligned proposal development
Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations
Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.
