A Culture-Free Platform for Rapid Pathogen Identification

DESCRIPTION provided by applicant Fungal sepsis or fungemia is a serious public health concern afflicting over patients every year in the US where almost of those do not survive In fungemia early targeted treatment is life saving and considering the rate at which the disease develops is perhaps the most crucial factor to improving outcomes Unfortunately given the time consuming diagnostic process today the underlying cause of this disease is typically identified too late Current diagnostics do not facilitate early initiation of a targeted antifungal intervention as they require culturing which requires as long as days for accurate identification of the infecting pathogen Hence current treatment protocols use andapos best guessandapos approaches which are not only less effective but likewise increase complications and increase the prevalence of drug resistant pathogens Having met our and exceeded our Phase I Specific Aims this Phase II proposal focuses on the automation of the entire diagnostic into a fully integrated sample to answer consumable enabling the automated species level identification of the most clinically prevalent fungal pathogens directly from phlebotomy specimens in roughly hours without human intervention The sample to answer diagnostic we will develop will have profound impact both by improving outcomes by providing a means to develop a hypothesis driven first line intervention and likewise by reducing the use of excessive and unnecessary antimicrobials To succeed in this Phase II we have put together a top notch team at HelixBind including experts in assay development application of synthetic nucleic acid analogues the design and implementation of sample to answer automated diagnostics and in biomedical instrumentation development Additionally we have enlisted key strategic advisors in clinical microbiology surface chemistry and nucleic acid analogues as well as successful entrepreneurs with experience in the development and commercialization of medical devices Together we will build upon our already impressive Phase I results having established species level capability at sub CFU ml sensitivity levels directly from spiked human samples To establish the performance capability our automated and culture free diagnostic we will culminate this Phase II by assessing the clinical specificity and sensitivity of our diagnostic wit the assistance of our clinical partner Having achieved our Phase II Specific Aims we will move forward and develop deployable instrumentation consumables and validate our entire diagnostic in preparation for the pivotal clinical trial PUBLIC HEALTH RELEVANCE Fungemia is a public health concern and accounts for nearly cases each year in the US where roughly do not survive The key to improving outcomes and reducing the mortality rate is rapid and accurate diagnosis which would enable a targeted first line intervention We propose to develop the first fully integrated sample to answer diagnostic capable of identifying the most prevalent fungal pathogens down to the species level as clinically required directly from phlebotomy samples days faster than currently possible The information provided by this diagnostic would enable the clinician to apply a more targeted and hence more effective first line treatment from the onset of symptoms