Advancing Development of Rapid Fungal Diagnostics (R01 Clinical Trial Not Allowed) | PA 19 080

Opportunity Information: Apply for PA 19 080

Advancing Development of Rapid Fungal Diagnostics (R01 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) discretionary grant opportunity (Funding Opportunity Number PA 19 080; CFDA 93.855) focused on improving how fungal infections are detected in real-world clinical settings. The central goal is to fund projects that move fungal diagnostic technologies forward so they are rapid, highly sensitive, highly specific, simple to use, and cost-effective, with a clear emphasis on deployment in primary health-care environments such as hospitals and point-of-care sites. In practical terms, the announcement is aimed at supporting diagnostic development work that can meaningfully shorten time to diagnosis, improve accuracy, and make testing more accessible in settings where fast decisions are needed.

The award mechanism is an R01 research project grant, and the opportunity explicitly states that clinical trials are not allowed under this announcement. That means applicants should propose research and development activities that advance diagnostic assays, platforms, workflows, or validation approaches without designing the project as a clinical trial. The intent is to support translational and applied diagnostic development that can lead to usable tests in frontline care, while staying within the NIH definition boundaries that distinguish product or assay development from clinical trial activity.

Eligibility is broad and includes many types of U.S.-based organizations and several special categories. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; and Native American tribal organizations other than federally recognized tribal governments. The program is also open to public housing authorities and Indian housing authorities, nonprofits with and without 501(c)(3) status (excluding higher education institutions where applicable), for-profit organizations (other than small businesses), and small businesses. In addition, the announcement highlights other eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations). This breadth signals NIH interest in drawing solutions from a wide range of research, clinical, and community-facing organizations, including groups positioned to address fungal diagnostic needs across diverse populations and settings.

Key administrative details included in the source information are that the opportunity is categorized as discretionary funding and uses the grant funding instrument type. The original closing date listed is 2022-01-07, and the opportunity record shows a creation date of 2018-11-26. The provided source fields do not specify an award ceiling or expected number of awards, indicating those details are either not fixed, not disclosed in the excerpt, or may vary by NIH institute, budget period, application cohort, or availability of funds.

Overall, this FOA is best understood as NIH support for practical diagnostic innovation in fungal disease: developing and refining tools that can deliver faster and more reliable results at or near the point of patient care, while keeping the proposed work within an R01 scope that does not involve conducting a clinical trial.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Advancing Development of Rapid Fungal Diagnostics (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2018-11-26.
• Applicants must submit their applications by 2022-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PA 19 080

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: