Addressing Health Inequities in Clinical Diagnostics (R43/R44 Clinical Trials Not Allowed) | PAR 24 158

Opportunity Information: Apply for PAR 24 158

The NIH funding opportunity "Addressing Health Inequities in Clinical Diagnostics (R43/R44 Clinical Trials Not Allowed)" (PAR-24-158) is a small business-focused grant program designed to push the development of better clinical diagnostic tests or alternative diagnostic approaches that reduce health disparities. The core idea is that some laboratory assays and point-of-care diagnostic devices do not work equally well across diverse patient groups because they were designed, calibrated, or validated using data and samples that do not adequately represent the full range of human diversity. When performance differences go unrecognized, those gaps can translate into missed diagnoses, delayed treatment, inappropriate care decisions, or unequal access to accurate screening and monitoring for certain populations. This NOFO aims to fund practical, development-oriented projects that directly identify a specific inequity tied to a diagnostic and then build a solution that improves fairness and performance across groups.

Projects under this opportunity are expected to start by clearly defining the problem: applicants should pinpoint a diagnostic (or class of diagnostics) where there is a credible equity concern, describe how the disparity shows up in real-world use (for example, differences in sensitivity, specificity, predictive value, reference ranges, or failure rates across demographic or clinical subgroups), and explain why this matters clinically. The application should then lay out a development plan to address the issue through an improved diagnostic, an alternative diagnostic method, or modifications that make the test more accurate and reliable in populations that have been historically underrepresented in research and product development. The emphasis is on development and translation, not on running clinical trials, and the announcement explicitly states that clinical trials are not allowed under this NOFO.

The funding mechanism is the NIH Small Business Innovation Research pathway using the R43/R44 activity codes, which generally align with Phase I (feasibility and early proof-of-concept) and Phase II (full research and development) work. In practical terms, this means the program is meant for Small Business Concerns that can take a clearly scoped diagnostic equity problem and move it toward a usable product or validated approach, including activities like assay redesign, improved calibration, more robust algorithms, better sampling strategies, expanded analytical validation across diverse specimens, usability improvements for point-of-care settings, and other engineering and translational steps that strengthen performance across populations. While the NOFO summary does not list an award ceiling or the expected number of awards, it is presented as a discretionary NIH grant opportunity, and applicants should expect the usual SBIR focus on milestone-driven R and D with a credible path to real-world adoption.

Eligibility is limited to small businesses; that is the only applicant category listed. Foreign organizations are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply. However, the notice indicates that foreign components, as defined by the NIH Grants Policy Statement, may be allowed, which typically means limited, well-justified involvement of non-U.S. elements could be permissible when essential to the project, but the applicant organization itself must be U.S.-based and eligible as an SBC.

Key administrative details included in the source information are that the sponsoring agency is the National Institutes of Health, the opportunity category is discretionary, and the funding instrument is a grant. The opportunity lists multiple CFDA numbers (93.172, 93.173, 93.350, 93.846, 93.867), reflecting that multiple NIH institutes or programs may participate. The original closing date shown is January 5, 2027, suggesting the NOFO is open for submissions across multiple receipt dates until that time, consistent with many NIH omnibus-style or multi-year solicitations.

Overall, this opportunity is best read as an SBIR-driven push to correct known or plausible diagnostic blind spots that disproportionately affect certain populations. Strong applications will be specific about the inequity, demonstrate why current diagnostics fall short for particular groups, and present a rigorous development plan that results in a diagnostic that performs more consistently and equitably, without proposing clinical trial activities under this announcement.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Addressing Health Inequities in Clinical Diagnostics (R43/R44 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 24 158

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