Expanding GeneCaptureÆs Rapid Portable IFI Diagnostic for Wound Infections

Infections in traumatic wounds are a large cause of mortality especially when they involve invasive fungal infections (IFI). Not all woundsĀharboring fungal organisms need treatmentĀas the wound may be merely contaminated or colonized. The Defense Health Agency requirement for a fieldable IFI diagnostic solution can be met using GeneCaptureÆs platform ID technology, currently being developed to report pathogen IDĀin about an hour in a portable Point-of-Care system designed for austere environments. The ID cartridges are being matured for market, use no enzymes, are stable in extreme environments, and allow sample-to-answer testing.ĀGeneCapture rapidly identifies the genetic signature of pathogens using itsĀōCAPTUREöĀ(Confirm Active Pathogens Through Unamplified RNA Expression) assayĀthat allows simplified logistics and low cost. The CAPTURE assay uses a microarray of structured probes targeting ribosomal RNA. When the target RNA binds, the DNA probes undergo a conformational change allowing a labeled reporter to bind. The signal across the array forms unique fingerprints to identify organisms at the level of species, family, or kingdom.Ā GeneCapture is also developing a rapid, sample-to-answerĀantimicrobial susceptibility test (AST) platform for bacterial wound infections andĀpropose to expand this approach toĀCandida. The small system automatically counts organisms before/after growth in the presence/absence of drug. Early phenotypic changes in growth correlate better with susceptibility than genotypic screens. The underservedĀCandidaĀmarket needsĀsame-day prescription of the correct drugĀdue to the widespread drug-resistance of its many species. GeneCapture is currently performing on a contractĀsupported by the US Army Military Infectious Disease Research ProgramĀthrough the Medical Technology Enterprise Consortium (MTEC)Āto expand our bacterial wound ID capabilities to identify the generaĀAspergillus, Fusarium, ScedosporiumĀand OrderĀMucorales.ĀĀThe initial testing of this preliminary IFI panelĀhas shown an impressiveĀ97% sensitivity and 100% specificity, and tissue samples have been shown to be an accepted matrix.ĀMTEC will not have funding to continue this work and has encouraged us to apply to DHA. Although the four molds initially targeted cause many traumatic IFI, we propose to use our established methods of probe design/panel verification to further include the commercially importantĀCandidaĀgenus, the FamilyHerpotrichiellaceaeĀ(containing many species causing phaeohyphomycosis), as well as a pan-fungal identification component. Since IFI may be caused by dozens of agents, a pan-fungal approach in combination with specific ID greatly expands the utility of the test to inform correct treatment. This broader, more mature panel will then be tested for inclusivity/exclusivity and the time post-exposure for the detection of infection versus contamination.ĀĀPre-clinical animal studies of this panel will then be proposed for Phase II work. Ā