Description:
Fast-Track proposals will be accepted.
Direct-to-Phase II proposals will not be accepted.
Number of anticipated awards: 2-3
Budget (total costs):
Phase I: $300,000 for up to one year;
Phase II: $1,500,000 for up to 3 years.
Background
Timely recognition and treatment of invasive fungal diseases (IFDs) is 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, 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 available antifungal therapies and a rise in fatal IFDs by previously rare fungal organisms such as the Mucorales and Fusarium spp. Assays that rapidly diagnose fungal infections will preserve the utility of the available antifungal therapies and reduce the inappropriate use of antibiotics.
Project Goal
The purpose of this project is to support the development of rapid, sensitive, specific, simple, and cost-effective diagnostics for primary health-care settings (hospitals and point-of-care (POC)) to detect IFDs.
Phase 1 activities may include, but are not limited to:
• Identification of appropriate biomarkers for a prototype POC diagnostic for invasive fungal diseases.
• Development of the prototype POC diagnostic product for detection of invasive fungal diseases.
• Determination of the sensitivity, specificity and other performance characteristics (e.g. time to result, limit of detection, test stability) of the prototype POC diagnostic.
Phase 2 activities may include, but are not limited to:
• Further characterization of appropriate biomarkers for a prototype POC diagnostic for invasive fungal diseases.
• Further development of the prototype POC diagnostic product for detection of invasive fungal diseases.
• Further determination of the sensitivity, specificity and other performance characteristics (e.g. time to result, limit of detection, test stability) of the product.
• Final validation testing and scale-up manufacturing of test kits.
This SBIR will not support:
• The design and conduct of clinical trials (see http://www.niaid.nih.gov/researchfunding/glossary/pages/c.aspx#clintrial for the NIH definition of a clinical trial). For clinical trial support, please refer to the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement program announcement or the NIAID Investigator-Initiated Clinical Trial Resources webpage.
• Proposals that do not include the identification of at least one of the following dimorphic fungi: Coccidioides spp, Histoplasma spp, Blastomyces spp, Paracoccidioides spp, Talaromyces spp, and Sporothrix spp.
