Addressing Health Inequities in Clinical Diagnostics (R41/R42 Clinical Trials Not Allowed) | PAR 24 157

Opportunity Information: Apply for PAR 24 157

The NIH funding opportunity "Addressing Health Inequities in Clinical Diagnostics (R41/R42 Clinical Trials Not Allowed)" (PAR-24-157) supports small businesses that want to improve existing clinical diagnostic tests or create alternative diagnostics that reduce health inequities tied to poor test performance in diverse patient populations. The core idea is that some laboratory assays and point-of-care devices were developed, calibrated, or validated using patient datasets that do not adequately represent the diversity seen in real-world clinical care. As a result, certain groups can experience higher rates of false negatives, false positives, misclassification, delayed diagnosis, or inappropriate clinical decisions. This NOFO asks applicants to pinpoint a specific diagnostic-related problem that contributes to inequity, clearly describe how and why the disparity occurs, and then design and develop a practical solution that directly addresses the identified gap.

This opportunity uses the NIH small business mechanisms R41/R42, meaning it follows the SBIR pathway (Small Business Innovation Research). In practice, that typically implies a phased development approach, with early-stage work focused on establishing feasibility and building proof-of-concept (Phase I, R41), and later-stage work focused on further development, refinement, and steps toward commercialization and broader deployment (Phase II, R42). The NOFO explicitly states that clinical trials are not allowed, so projects should be structured around non-clinical-trial activities such as assay/device engineering, analytical validation, algorithm refinement, usability engineering, studies using banked/de-identified specimens, retrospective performance analyses, or other development and validation work that does not meet NIH's definition of a clinical trial.

Eligibility is limited to U.S. small business concerns. Foreign organizations cannot apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, the announcement notes that foreign components (as defined in the NIH Grants Policy Statement) may be allowed in some situations, which usually means certain discrete elements of the project can be performed outside the U.S. if they are well-justified and consistent with NIH policy, but the applicant organization itself must be an eligible U.S. small business and the overall project must meet all SBIR requirements.

From a practical application standpoint, the NIH is looking for teams that can do three things well: first, identify a real diagnostic inequity problem with a clear link between the diagnostic and downstream disparities; second, demonstrate a credible understanding of what drives the inequity (for example, biased reference ranges, insufficient representation in training/validation cohorts, biological variability not accounted for, device design and sampling issues, environmental or skin tone effects on optical sensors, or other factors that degrade performance for certain populations); and third, propose a development plan that results in a better diagnostic, a better algorithm, a better calibration/interpretation framework, or a new alternative test that performs more equitably across diverse groups. Strong projects typically make the disparity measurable, define the intended use and target population precisely, and lay out how performance will be evaluated across relevant demographic and clinical subgroups in a way that is scientifically rigorous and actionable.

Administrative details from the notice include that it is a discretionary grant opportunity administered by the National Institutes of Health, with funding activity in the health area, and associated with CFDA numbers 93.172, 93.173, 93.350, 93.846, and 93.867. The posting indicates an original closing date of 2027-01-05, suggesting a multi-year window with recurring due dates or an extended submission period typical of some NIH omnibus-style small business announcements. The award ceiling and expected number of awards are not specified in the provided source text, so applicants would need to consult the full NOFO for budget limits, project period expectations, and any institute-specific participation details.

Overall, PAR-24-157 is aimed at pushing diagnostic innovation in a direction that is explicitly equity-focused: not just making tests more advanced, but making them work reliably for the full range of people who will rely on them in clinical care. It targets the real-world consequences of under-representative development and validation practices and encourages small businesses to translate an identified disparity into a concrete, testable, development roadmap that improves diagnostic fairness without conducting clinical trials under this award.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Addressing Health Inequities in Clinical Diagnostics (R41/R42 Clinical Trials Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.172, 93.173, 93.350, 93.846, 93.867.
• This funding opportunity was created on 2024-02-28.
• Applicants must submit their applications by 2027-01-05.
• Eligible applicants include: Small businesses.

Apply for PAR 24 157

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