Innovative Approaches to Target Identification and Assay Development for Fungal Diagnosis (R21/R33) | Apply Online

Opportunity Summary:

The NIH National Institute of Allergy and Infectious Diseases (NIAID) released this Funding Opportunity Announcement, RFA-AI-08-055, to push forward new ways to identify diagnostic targets and build practical assays for serious fungal infections, with invasive aspergillosis (IA) as a required focus. The core problem it aims to address is that immunocompromised and immunosuppressed patients are at high risk for invasive fungal diseases, yet timely, accurate diagnosis remains difficult. The FOA is designed to bring together two groups that do not always work closely enough: mycology researchers who understand fungal biology and disease, and innovators in diagnostics and technology who can translate biological insights into real-world tests. The end goal is not just publishing findings, but producing a new diagnostic test or tests for invasive fungal disease that must include invasive aspergillosis and can realistically move toward clinical use.

The scientific scope is centered on discovering and validating novel clinical diagnostic targets (for example, fungal biomarkers, antigens, nucleic acid signatures, metabolites, host-response markers, or other measurable signals tied to infection) and then turning those targets into assays that can detect disease more reliably or earlier than existing approaches. The FOA emphasizes innovation in both target identification and assay development, meaning applicants are expected to propose ideas that go beyond incremental tweaks. Projects can also include enabling technologies and diagnostic strategies that make detection feasible in realistic clinical workflows, especially in patient populations where rapid decisions matter.

This opportunity uses the NIH R21/R33 Phased Innovation Award mechanism, which is built for high-risk, high-reward development work that needs a structured path from concept to early translation. The R21 phase supports exploratory and developmental work to establish feasibility, guided by clearly defined milestones. In practice, that means applicants are expected to outline what success looks like early on: what performance benchmarks will be met, what proof-of-concept data will be generated, and what go/no-go criteria will determine whether the project is ready to advance. If those milestones are achieved, the project can transition to the R33 phase, which provides support to translate the successful innovation into the preclinical or clinical development pipeline. The intent is to avoid projects stalling at the early discovery stage by providing a built-in route toward practical development when early results justify it.

On funding, NIAID planned a total commitment of about $1.5 million in fiscal year 2010 for this announcement, with an expected five to seven awards. Because projects may differ widely in technical approach, complexity, and readiness level, the FOA notes that the size and duration of individual awards may vary. Awards are to be made based on scientific and technical merit, alignment with program priorities, and the availability of funds, which is standard for NIH discretionary grant programs.

Eligibility is broad and includes many types of domestic and non-domestic organizations. Eligible applicants listed include public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (other than small businesses, though small businesses are also eligible), state, county, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities. The FOA also explicitly includes a range of mission-focused institutions and organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based and community-based organizations, tribal governments and tribal organizations, U.S. territories or possessions, regional organizations, and foreign organizations or other non-U.S. entities. There is no cost sharing or matching requirement, which lowers barriers for applicants who might otherwise struggle to commit non-federal funds.

Key administrative details include that the opportunity is categorized as a discretionary grant in the health area under CFDA 93.856 (Microbiology and Infectious Diseases Research). The FOA was posted on October 8, 2008, with an original closing date of February 11, 2009, later extended to February 26, 2009, and it was archived on March 26, 2009. The full announcement was made available through the NIH Grants Guide, and NIH’s Office of Extramural Research provided webmaster contact support for access and linking issues.

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