NIH/NIAID – Advancing Development of Rapid Fungal Diagnostics (R01, R21 Clinical Trial Not Allowed)

December 3, 2018 by School of Medicine Webmaster

The following description was taken from the R01 version of this FOA.

The purpose of this Funding Opportunity Announcement is to support the development of rapid, sensitive, specific, simple, and cost-effective diagnostics for primary health-care settings (hospitals and point-of-care).


Timely recognition and treatment of invasive fungal diseases (IFDs) are necessary to reduce the morbidity, mortality and inappropriate antibiotic usage commonly associated with IFDs. Recent medical advances in the management of cancer patients and hematopoietic stem cell and organ transplantation, in addition to immunocompromising diseases, such as AIDS (Acquired Immunodeficiency Syndrome), have created an expanding population at risk for IFDs.  Unfortunately, the management of patients with suspected IFDs often involves empiric, prophylactic antifungal therapy until the results of time-consuming culture-based and/or highly technical assays are made available.  The prophylactic use of antifungal agents is associated with an increase in resistance to the four classes of antifungal therapies and a rise in fatal IFDs by previously rare fungal organisms such as the Mucorales and Fusarium spp.  Assays to rapidly diagnose fungal infections will preserve the utility of the available antifungal therapies and reduce the inappropriate use of antibiotics.

Specific areas of research interest

This FOA will support diagnostics research activities, including efforts to: 1) identify biomarkers of invasive fungal disease and/or determine antifungal susceptibility, 2) develop an assay to reliably demonstrate the presence or absence of novel biomarkers or determine drug sensitivities, 3) explore and assess strategies for optimizing sample type and/or sample volume, and develop or improve concentration or enrichment methods to support overall assay development in any novel diagnostic schema, 4) apply technological/methodological advancement strategies in both target identification and assay development, which may include approaches designed to substantially improve existing methods. Diagnostic approaches that detect one or more fungal pathogens and provide results more rapidly than current culture-dependent methods are strongly encouraged.

It is possible that a single target either from the pathogen or induced via the host’s response will be insufficient to provide the required sensitivity and specific early diagnostic capabilities.  Identification of multiple targets and development of a multiplex assay(s) may be required to distinguish between a fungal pathogen only colonizing a host verses causing active disease, as well as identifying the infectious agent.

For the purposes of this FOA, the following diagnostic performance parameters are of greatest importance:

  • Rapid: Ideal diagnostic test time of approximately 20 minutes to 2 hours for identification of species and determination of susceptibility profiles, which includes the time-required to process the clinical sample (if appropriate) through detection and delivery of the final test result.
  • Sensitive: Sensitivity should be equivalent to or exceed current FDA-cleared standards for proposed targets from the same sample type.
  • Specific: Specificity should be equivalent to or exceed current FDA-cleared standards for proposed targets from the same sample type.
  • Easy-to-use: Integrated, closed sample-to-answer system with automated data analyses and/or result presentation and with minimal operator training and expertise required, for example a Lateral flow assay device.
  • Cost-effective: Projected production and operating costs should be consistent with commonly used platforms for detecting infectious disease-causing pathogens.
  • Where appropriate, enable multiplexed differential detection of multiple pathogens.

PA-19-080 uses the R01 grant mechanism, PA-19-081 uses the R21 mechanism. High risk/high payoff projects that lack preliminary data or utilize existing data may be most appropriate for the R21 mechanism. Applicants with preliminary data and/or planning to include longitudinal analysis may wish to apply using the R01 mechanism.

Deadlines:  standard dates apply


Filed Under: Funding Opportunities