Non-invasive Diagnostics to Improve Gynecologic Health (R43/R44 Clinical Trial Optional) | RFA HD 20 019

Opportunity Information: Apply for RFA HD 20 019

This funding opportunity, titled "Non-invasive Diagnostics to Improve Gynecologic Health (R43/R44 Clinical Trial Optional)" (RFA-HD-20-019), is a National Institutes of Health (NIH) small business grant aimed at speeding up and improving how certain common gynecologic conditions are diagnosed. The focus is on developing and validating new non-invasive or less-invasive diagnostic and/or screening tools for endometriosis, adenomyosis, and uterine fibroids. In practical terms, NIH is looking to support technologies and approaches that can move diagnosis away from procedures that are burdensome, costly, difficult to access, or dependent on invasive surgical confirmation, and toward methods that are easier to use, safer for patients, and more widely available in routine care.

The core purpose of the program is to shorten the time it takes patients to get an accurate diagnosis and to reduce reliance on invasive diagnostic techniques. Conditions like endometriosis and adenomyosis are often associated with long diagnostic delays and symptom overlap with other disorders, and uterine fibroids can require imaging and specialist evaluation that may not be equally accessible across settings. This FOA is meant to incentivize solutions that improve real-world diagnostic pathways: tools that could be used earlier in the clinical workup, that reduce unnecessary procedures, and that lower overall barriers to getting diagnosed, including barriers related to cost, convenience, safety, and availability of trained specialists.

The announcement emphasizes collaboration, encouraging small businesses to work closely with scientists and clinicians who understand gynecologic health and the realities of patient care. That collaboration element signals that NIH expects projects to be clinically grounded, with clear plans for how a proposed diagnostic or screening method would fit into medical decision-making. Technologies supported under this FOA could include new devices, assays, biomarkers, imaging approaches, point-of-care platforms, or integrated diagnostic methods, as long as the end goal is non-invasive diagnosis or screening with meaningful clinical utility. The FOA also notes that clinical trials are optional, which typically means applicants may propose either preclinical development and validation work or include clinical evaluation when appropriate for the stage of the technology.

From an administrative standpoint, this is a discretionary grant in the health-related assistance category, listed under CFDA 93.865, and it uses the SBIR/STTR-style R43/R44 mechanism (small business-focused phased awards). Eligibility is limited to small businesses, reinforcing that the program is designed to translate innovations toward commercialization and real-world deployment rather than to fund general academic research alone. The opportunity is run by NIH, created on 2019-09-17, with an original closing date of 2019-12-10.

The eligibility rules also make clear that non-U.S. entities cannot apply as the applicant organization. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply as components of the project. However, the FOA leaves room for "foreign components" as defined by NIH policy to be allowed in some cases, which typically means a U.S. small business may be able to incorporate certain foreign activities or collaborations if they meet NIH requirements and are appropriately justified. The key point is that the applying organization must be an eligible U.S. small business, and applicants would need to consult the FOA and NIH Grants Policy Statement definitions to understand what, if any, foreign component activity is permissible.

Overall, the opportunity is aimed at moving the field toward faster, safer, more accessible diagnostic and screening options for endometriosis, adenomyosis, and uterine fibroids, with an emphasis on practical clinical impact and translation. Projects are expected to advance tools that could reduce diagnostic delays, decrease invasiveness, and improve the patient and provider experience while also addressing cost and scalability so that improved diagnostics can realistically reach routine gynecologic care.

• 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 2019-09-17.
• Applicants must submit their applications by 2019-12-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

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