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.Apply for PAR 24 157
- 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.
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FAQs: Addressing Health Inequities in Clinical Diagnostics (R41/R42 Clinical Trials Not Allowed) (PAR-24-157)
What is this NIH funding opportunity?
PAR-24-157 is an NIH funding opportunity focused on improving clinical diagnostic tests in ways that reduce health inequities. It supports small businesses developing improvements to existing diagnostics or creating alternative diagnostics when current test performance is worse for certain populations in real-world care.
What problem is NIH trying to solve with this opportunity?
NIH is targeting diagnostic-related inequities that happen when tests, assays, devices, or interpretation algorithms were developed, calibrated, or validated using datasets that do not reflect the diversity of patients seen in practice. When diagnostic performance varies across groups, it can lead to higher false negatives, false positives, misclassification, delayed diagnosis, and inappropriate clinical decisions for affected populations.
What types of applicants is NIH looking for?
This opportunity is intended for U.S. small business concerns proposing equity-focused diagnostic innovation. Strong applicants typically (1) identify a specific diagnostic inequity problem, (2) explain how and why the disparity happens, and (3) propose a practical development plan to fix the gap and evaluate performance across relevant demographic and clinical subgroups.
What funding mechanisms does this use?
The announcement uses NIH small business mechanisms R41 and R42, which follow the SBIR (Small Business Innovation Research) pathway. This usually implies a phased approach: Phase I (R41) for feasibility and proof-of-concept work, followed by Phase II (R42) for further development, refinement, and steps toward commercialization and broader deployment.
Are clinical trials allowed under this NOFO?
No. The NOFO explicitly states "Clinical Trials Not Allowed." Projects should be designed around development and validation activities that do not meet NIH's definition of a clinical trial.
What kinds of activities are appropriate since clinical trials are not allowed?
Examples of allowed, non-clinical-trial activities mentioned or implied in the notice include assay or device engineering, analytical validation, algorithm refinement, usability engineering, studies using banked or de-identified specimens, and retrospective performance analyses. The overall project should remain within non-clinical-trial development and validation work.
What is NIH expecting applicants to describe in the proposal?
Applicants are expected to pinpoint a specific diagnostic-related problem tied to inequity, clearly describe how and why the disparity occurs, and then design and develop a solution that directly addresses the identified gap. The opportunity emphasizes making the disparity measurable, defining intended use and the target population precisely, and evaluating performance across relevant subgroups in a scientifically rigorous and actionable way.
What are examples of factors that can drive diagnostic inequities?
The notice highlights several possible drivers, such as biased reference ranges, insufficient representation in training or validation cohorts, biological variability that is not accounted for, device design and sampling issues, and environmental or skin tone effects on optical sensors. More broadly, the focus is on any factor that causes a test to perform worse for certain populations.
Does this opportunity support improving existing diagnostics, or only new diagnostics?
It supports both. Small businesses can propose improvements to existing clinical diagnostic tests or propose alternative diagnostics that reduce inequities linked to poor performance in diverse patient populations.
What does "equity-focused diagnostic innovation" mean in this NOFO?
In this context, it means advancing diagnostics so they work reliably across the full range of people who will use them in clinical care. The goal is not only better technology, but better and more equitable performance across diverse groups, reducing downstream disparities caused by uneven diagnostic accuracy.
Who is eligible to apply?
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.
Are any foreign activities allowed if the applicant is a U.S. small business?
The notice indicates that foreign components (as defined in the NIH Grants Policy Statement) may be allowed in some situations. This typically means discrete project elements may be performed outside the U.S. if well-justified and consistent with NIH policy, while the applicant organization remains an eligible U.S. small business and the project meets SBIR requirements.
What outcomes is NIH looking for by the end of the project?
The NOFO emphasizes deliverable solutions such as a better diagnostic, a better algorithm, a better calibration or interpretation framework, or an alternative test that performs more equitably across diverse groups. The development plan should be practical and oriented toward real-world deployment and commercialization (consistent with the SBIR pathway).
How should applicants think about evaluating diagnostic performance in this program?
The opportunity stresses evaluating performance across relevant demographic and clinical subgroups in a rigorous and actionable way. Projects that define intended use and target population precisely and measure the disparity directly are positioned as stronger fits.
What is the administering agency and general category of this grant?
This is a discretionary grant opportunity administered by the National Institutes of Health (NIH) in the health area.
What CFDA numbers are associated with this opportunity?
The notice references CFDA numbers 93.172, 93.173, 93.350, 93.846, and 93.867.
What is the closing date?
The posting indicates an original closing date of 2027-01-05, suggesting a multi-year window that may include recurring due dates or an extended submission period typical of some NIH small business announcements.
Does the provided information list the award ceiling or number of expected awards?
No. The source text provided does not specify an award ceiling or expected number of awards. Applicants would need to consult the full NOFO for budget limits, project period expectations, and any institute-specific participation details.
What is the main takeaway for teams considering applying?
This NOFO is aimed at translating a specific, documented diagnostic disparity into a concrete development roadmap that improves diagnostic fairness, without conducting clinical trials under this award.
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