SBIR-STTR Award

GeneCapture is proposing to use its rapid CAPTURE assay (Confirm Active Pathogens Through Unamplified RNA Expression) to identify the pathogen(s) in wound infections. The pathogen Infection Diagnostic (ID)test takes place in a disposable cartridge that integrates and automates the sample prep steps and determines the genetic signature of the pathogens present. The assay is based on immobilized stem loop probes that are designed to bind to the pathogenic RNA. Once bound, the captors indicate the presence and concentration of the pathogens as measured by quantitative fluorescence. The assay has been validated for several ESKAPE pathogens. Once the pathogen is identified, our planned fully integrated system will perform a rapid phenotypic Antibiotic Susceptibility Test which will measure labelled pathogen-specific bacterial growth in the presence of specific antibiotics, and controls, in a disposable cartridge. Each test (ID and AST) is expected to report in approximately 30 minutes. A single portable reader instrument is proposed which will accept both the ID and AST disposable cartridges. This enzyme-free protocol is designed to operate in austere environments, does not require cold chain for any of the disposables or consumables, and the reader can be operated by battery power.

GeneCapture proposes to develop and test an automated wound pathogen identification (ID) and Antibiotic Susceptibility Test (AST) system with strong dual-use potential in both the Military and Commercial Point-of-Care markets. The TRL6 ID test will distinguish multiple pathogens from the same sample using the company’s patented CAPTURE (Confirming Active Pathogens Through Unamplified RNA Expression) platform that reports a specific ‘signature profile’ for each targeted organism. GeneCapture will finalize its Wound ID Panel, that was developed in the Phase I work to target ESKAPE pathogens. to include other important wound pathogens. The software algorithm that automatically identifies the pathogen will be strengthened with additional data sets. Testing the ID system against pre-clinical and clinical samples will prove its sensitivity and specificity. Initial stability testing will be performed in simulated desert and jungle environments. The ID cartridge result will be used to guide the Antibiotic Susceptibility Test (AST), which will be prototyped into a Sample-to-Answer TRL4 system and validated during the project. A flow cytometry technique will be employed to report the AST results for mixed pathogen samples, as was proven in the Phase I effort. The AST cartridges will be made available for pre-clinical testing. The instrument to read the ID and AST cartridges will be upgraded from the current prototype and delivered for testing. A data package for inclusion in the application to the U.S. FDA will be developed leading to a portable CLIA-waived ID and AST solution for the point-of-care.