Infectious disease has now entered a post-antibiotic era where multi-drug resistance is increasingly common. There is an immediate need for new diagnostics that can determine the susceptibility of pathogenic bacteria to antibiotics rapidly and accelerate the administration of targeted therapy for optimal patient outcomes. BioSense Technologies proposes the development of a new phenotypic assay for determining antibiotic minimum inhibitory concentrations (MIC) in 60 minutes. The technology monitors the development of antibiotic- induced cellular stress as an early response for determining the effect of therapeutic agents on cellular suspensions. The immediacy and ubiquity of the response enables near real-time assessment of all bacterial species treated with drugs having different mechanisms of action. We propose to demonstrate feasibility of the approach by measuring the early responses of isolates spanning a wide range of MIC values for six organism-antibiotic combinations to construct susceptibility response profiles and corresponding database. The Phase I effort will conclude with a blinded study to validate the technical approach. In Phase II additional organism-antibiotic combinations will be studied including all important resistance mechanisms and platform hardware will be expanded to accommodate measurement of a larger number of therapeutic agents.
The treatment of infectious diseases has now entered the post-antibiotic era where drug resistant infections are commonplace as our arsenal of effective therapies dwindles. There is an immediate need for new technologies to identify drug resistance as quickly as possible to administer targeted therapies. Existing automated antibiotic susceptibility testing systems have assay times of 6-12 hours or more depending on the organism and next day turn-around-times delaying the administration of targeted therapy. The successful development of the proposed near real-time antibiotic susceptibility technology will address this public health crisis directly as part of a new generation of clinical microbiology laboratory diagnostics. The ability to pair rapid AST results with rapid ID measurements having commensurate TAT such as the recent FDA approved MALTI-TOF mass spectrometry systems, would enable same-day results and significantly impact the administration of inappropriate therapies and overall antibiotic stewardship.
