Addressing Health Inequities in Clinical Diagnostics (R43/R44 Clinical Trials Not Allowed)
Small businesses can get funding to create better clinical diagnostics that fix health disparities caused by current tests that don't work well for everyone.
This grant is no longer accepting proposals
National Institutes of Health has archived this opportunity.
Funder: [National Institutes of Health - https://www.nih.gov]
Due Dates: January 5, 2027 (Next due date) | Recurring standard SBIR/STTR due dates apply
Funding Amounts: Phase I: Typically 6-12 months; Phase II: Typically 2 years; budgets vary by IC, with possible waivers for larger awards. Fee up to 7% allowed.
Summary: Supports small businesses in developing improved clinical diagnostics that address health disparities caused by current assays or devices lacking diverse patient representation.
Key Information: Clinical trials are not allowed under this FOA; foreign involvement must be justified and disclosed; applicants must be U.S.-based small businesses.
Description
This funding opportunity encourages Small Business Concerns (SBCs) to develop improved or alternative clinical diagnostics that specifically address health inequities caused by existing clinical laboratory assays and point-of-care devices that do not adequately incorporate diverse patient populations. Applicants must identify and clearly define a health disparity perpetuated by current diagnostics and propose innovative solutions to mitigate these disparities.
The program is part of the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) initiatives, which provide non-dilutive funding to U.S.-based small businesses for early-stage healthcare product development with strong commercialization potential.
Key aspects:
- Focus on diagnostics that reduce health disparities by improving accuracy, reliability, or accessibility for diverse populations.
- Clinical trials are not allowed under this FOA.
- Applicants must be U.S.-based small businesses meeting SBIR/STTR eligibility.
- Foreign components or collaborations are allowed only under rare, justified circumstances and require prior approval.
- Disclosure of all foreign affiliations and relationships is mandatory for applications submitted on or after September 5, 2023.
- The program supports Phase I (feasibility) and Phase II (research and development) projects, with an optional Commercialization Readiness Pilot (CRP) for late-stage development.
- Applicants are encouraged to contact NIH program officials for guidance on program fit and budget limits.
