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Partnerships for Diagnostics to Address Antimicrobial Resistance

The National Institutes of Health is soliciting research applications for projects focused on development of diagnostics that will enable rapid, sensitive, specific, culture-independent detection of high-priority antimicrobial-resistant Gram-negative bacterial pathogens.

The effort is focused on select healthcare-associated bacteria where resistance compromises effective treatment, including: Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter species and extra-intestinal pathogenic Escherichia coli.

Development of rapid and informative diagnostics will help clinicians to quickly determine the most effective treatment for infected individuals and will facilitate antimicrobial stewardship by reducing the empiric use of broad-spectrum antimicrobials.  Additionally, such diagnostics would benefit development and approval of new antibacterials by reducing the diagnostic uncertainty that necessitates enrollment of large numbers of patients who may not be evaluable in pivotal efficacy trials. Hence, rapid diagnostics should provide a means to reduce the size and cost of antibacterial clinical trials.

The proposed diagnostic must be designed to detect the target pathogens in normally sterile sample types such as blood, cerebral spinal fluid and pleural fluid.  The diagnostic may also include the detection of the target pathogens in the context of non-sterile sample types, such as for hospital- or ventilator-associated pneumonia. The proposed platforms must be supported by proof-of-concept data demonstrating feasibility. Examples of research areas supported include:

  • Assay or prototype development
  • Sample preparation
  • Development of broad-spectrum platforms or production technologies
  • Adaptation of products or platform technologies to new applications
  • Optimization of products or technologies
  • Process development
  • Diagnostic validation

Applications must include a Product Development Strategy and demonstrate substantive participation by at least one industrial participant.

Further details are available under RFA-AI-14-019.

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