Non-invasive Diagnostics to Improve Gynecologic Health (R43/R44 Clinical Trial Optional) | RFA HD 21 020

Opportunity Information: Apply for RFA HD 21 020

The NIH funding opportunity titled "Non-invasive Diagnostics to Improve Gynecologic Health (R43/R44 Clinical Trial Optional)" (RFA-HD-21-020) is an SBIR-focused grant program designed to help small businesses develop and commercialize better, less invasive ways to diagnose and/or screen for three common and often hard-to-diagnose gynecologic conditions: endometriosis, adenomyosis, and uterine fibroids. The central problem the program is trying to solve is the long delay many patients experience before receiving an accurate diagnosis, along with the limitations of current diagnostic pathways that can be invasive, costly, or difficult to access, especially outside major medical centers. By funding targeted research and development, the FOA aims to move promising diagnostic concepts toward practical products that can be used safely and effectively in real clinical settings.

A defining feature of this opportunity is its emphasis on advanced and enabling technologies. The solicitation explicitly points to platforms like biochips, microfluidics, and mobile technologies, but the intent is broader than those examples: applicants are encouraged to bring sophisticated engineering and analytical approaches into gynecologic health diagnostics, including tools that may not traditionally be associated with this clinical area. The program also puts real weight on cross-disciplinary collaboration, encouraging partnerships between small businesses and experts from diverse fields. In practice, that means a strong application is likely to include both technical innovation (for example, novel assay chemistry, biosensing, sample prep, signal processing, or device engineering) and clinical expertise (such as gynecology, radiology, pathology, reproductive endocrinology, or implementation science) to ensure the product targets a clear clinical need and can realistically be adopted.

The funded projects are expected to produce either integrated diagnostic systems or components that can plug into existing diagnostic workflows without excessive friction. In other words, NIH is not simply looking for interesting lab demonstrations; it is looking for technologies that can be engineered into robust products or product-ready subsystems. The FOA highlights practical design expectations that matter for eventual real-world use, including reliability and robustness (performance that holds up across users and environments), safety, and simplicity (a workflow that is not overly complex). It also calls out the importance of using appropriate baseline information and "contextual awareness," which signals an interest in tools that interpret results in a clinically meaningful way rather than producing raw measurements without decision support. Where relevant, software that assists with decision-making is encouraged, which could include algorithms that help clinicians interpret signals, integrate patient context, or standardize readouts across settings.

Another major theme is translational readiness: proposed technologies should incorporate existing standards where possible and account for regulatory requirements. This points applicants toward designing with eventual FDA or other regulatory pathways in mind, building evidence and documentation that supports safety and effectiveness claims, and aligning the product with clinical quality expectations. The FOA also encourages applicants to highlight cost-effectiveness and improved access, particularly for underserved areas. That can include designs that lower per-test cost, reduce the need for specialized staff or equipment, enable decentralized testing, or improve usability in clinics with fewer resources. The underlying message is that even a high-performing diagnostic will have limited impact if it cannot be deployed broadly, affordably, and consistently.

Projects that address a specific and well-characterized clinical need within endometriosis, adenomyosis, and/or uterine fibroids are framed as especially high-impact. This favors proposals that clearly define the use case (who the test is for, when it is used, what decision it informs, and what it replaces or improves), identify the current clinical gap (for example, diagnostic delay, need for invasive procedures, poor specificity, limited access to imaging, or inconsistent interpretation), and show how the proposed tool measurably improves on that gap. The program anticipates that, through rigorous collaborative R and D, applicants can produce safe and effective instruments, devices, or techniques that meaningfully improve evaluation and diagnosis for patients affected by these conditions.

From an administrative standpoint, the opportunity uses the NIH SBIR mechanisms R43 and R44, with clinical trials listed as optional, meaning projects may include clinical trial components when appropriate but are not required to do so. The agency is the National Institutes of Health, the funding instrument is a grant, and the activity area falls under health-related research and development (CFDA 93.865). Eligibility is limited to small businesses. Non-U.S. (non-domestic) entities and non-U.S. components of U.S. organizations are not eligible to apply, although foreign components may be allowed under NIH policy as defined in the NIH Grants Policy Statement. The opportunity record shows an original closing date of 2020-12-10 and a creation date of 2020-07-02.

Overall, this FOA is geared toward small companies that can combine technical innovation with a clear commercialization path to deliver non-invasive, patient-centered diagnostic or screening solutions for endometriosis, adenomyosis, and uterine fibroids. The strongest fit is a proposal that goes beyond proof-of-concept and demonstrates a credible plan to build something clinicians can use, patients can access, and health systems can afford, while also anticipating regulatory and integration realities from the start.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Non-invasive Diagnostics to Improve Gynecologic Health (R43/R44 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
• This funding opportunity was created on 2020-07-02.
• Applicants must submit their applications by 2020-12-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for RFA HD 21 020

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