049 Phage-based Diagnostic Platforms for Rapid Detection of Bacterial Pathogens
Fast-Track proposals will be accepted.
Direct to Phase II proposals will be accepted.
Number of anticipated awards: 2-3
Budget (total costs):
Phase I: $225,000 for up to one year
Phase II: $1,500,000 for up to 3 years
Resistance of bacterial pathogens to antibiotics is rapidly increasing, both in hospital environments and community settings, and it has become a national priority to find product-based solutions to this serious medical problem. Consequently, there is an urgent need for rapid, highly sensitive, easy-to-use, cost-effective clinical diagnostics that can identify bacterial pathogens and determine antibiotic susceptibility. Such diagnostic platforms have the potential to impact antibacterial resistance by helping physicians to determine the most effective treatments for infected individuals and thereby reduce the use of broad-spectrum antibiotics. In addition, these platforms may also support more efficient stratification of patients for clinical trials. Bacteriophages in particular offer many desirable characteristics which make them well-suited as a platform for rapid bacterial diagnostics tests. They are easily produced, remarkably diverse and target bacteria with exquisite specificity. The use of bacteriophage may also allow for detection of bacterial pathogens directly from clinical samples and potentially eliminate the need for primary culture methods. Assays utilizing phage detection in combination with drug testing offer the potential not only for pathogen identification but also for rapid determination of antibiotic susceptibility profiles critical for appropriate treatment decisions in the clinic.
The goal of this project is to leverage bacteriophages or their relevant biochemical components as tools for the development of rapid diagnostic platforms to detect bacterial pathogens that cause serious infections in humans. Responsive proposals must address bacteria recently classified by the Centers for Disease Control and Prevention (CDC) as antibiotic resistance threats. Because drug resistance is key to the threat posed by these pathogens, bacteriophage-based diagnostic platforms that can both identify the pathogens, as well as provide an assessment of antibiotic susceptibility, are preferred.
Phase I activities can include but are not limited to:
• Detailed characterization of specific bacteriophages, or relevant biochemical components, that demonstrate utility for detecting clinically-relevant bacterial pathogens.
• Determination of diagnostic sensitivity and selectivity sufficient to meet the needs of the intended clinical application.
• Development of a prototype device that can identify one or more target pathogens and their antibiotic susceptibility in a spiked specimen matrix that represents the intended clinical application.
Phase II activities can include but are not limited to:
• Demonstration that prototype device detects, with sufficient sensitivity and selectivity, a representative sampling of bacterial pathogens found in the clinic.
• Demonstration of feasibility for determining antibiotic susceptibility using well-characterized clinical isolates of target pathogen(s).
• Development of standardized plan for manufacturing of components.
• Validation of diagnostic device prototype with blinded clinical samples.
• Development of a product development plan for achieving regulatory approval and demonstrating clinical utility for bacteriophage-based detection system.
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.