Description:
Fast-Track proposals will be accepted.
Direct-to-Phase II proposals will not be accepted.
Number of anticipated awards: 3-4
Budget (total costs):
Phase I: up to $300,000 for up to 1 year;
Phase II: up to $1,500,000 for up to 3 years.
Background
Diarrheal diseases are the 5th leading cause of mortality in children less than 5 years of age (Lancet Infect Dis 2018; 18:
1211–28) and antimicrobial resistance in the causative agents is increasingly problematic (CDC report: Antibiotic Threats in
the United States 2019). Recent technological advances may facilitate the development of simple, rapid and inexpensive
point-of-care diagnostics for the detection of enteric bacterial and parasitic pathogens in children under five years of age with
moderate to severe diarrheal disease. Rapid identification of the pathogen(s) and associated antimicrobial resistance
profile(s) are needed to determine treatment options, especially for infants under 12 months of age for whom persistent
diarrheal disease is particularly risky.
Project Goal
The goal is to develop a rapid (≤ one hour) point-of-care diagnostic capable of detecting infectious enteric pathogens (≥ two)
and associated antimicrobial resistance profile(s) directly from patient specimens (e.g., stool samples). The end product must
identify antimicrobial resistance profiles; detection of both bacterial and parasitic pathogens in the same device is strongly
encouraged where feasible. Diagnostic devices and associated methodologies, e.g., microfluidic PCR, should be designed for
use in clinical or field settings, such as physician’s offices or in the field during outbreaks of diarrheal disease that impact the
population across all ages. Diagnostics that focus on multiple enteric bacterial pathogens with known drug resistance, as
well as parasitic pathogens, such as Giardia and Cryptosporidium, would be considered responsive.
Phase 1 activities may include, but are not limited to:
• Define the targets for pathogen identification
• Identify the antimicrobial resistance markers
• Demonstrate assay feasibility for rapid detection of enteric pathogens and their antimicrobial resistance profiles
• Develop sample preparation methods consistent with the product platform
• Conduct validation testing of true clinical specimens
Phase 2 activities may include, but are not limited to:
• Integrate platform and assay for rapid detection of enteric pathogens and antibiotic resistance profiles
• Conduct final analytical validation testing and scale-up manufacturing of test kits
• Complete development of the final prototype product up to, but not including, verification
This SBIR will not support:
• The design or conduct of clinical trials; please see https://grants.nih.gov/policy/clinical-trials/definition.htm for the NIH
definition of a clinical trial.
