A sample-to-answer diagnostic for neonatal blood stream infections

DESCRIPTION provided by applicant Neonatal sepsis is a serious public health concern afflicting of all live births and accounts for nearly of all neonate mortalities In neonatal sepsis 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 an early initiation of a targeed first line antimicrobial intervention as they require culturing which requires as long as day for accurate identification of the infecting pathogen Hence current treatment protocols employ empirically designed antibiotic andapos cocktailsandapos which are not only less effective but likewise increas complications and significantly increase the prevalence of drug resistant pathogens This proposal will remove the andapos culturing barrierandapos by demonstrating the feasibility of classifying the most clinically prevalent pathogens directly from phlebotomy samples in an automated manner This diagnostic will be the first to leverage the innovative use of a new synthetic nucleic acid analogue which has ability to invade double stranded DNA enabling the development of a rapid diagnostic assay with unparalleled sensitivity and accuracy Our innovative diagnostic approach would enable a significantly faster more sensitive and more accurate method of identifying neonatal sepsis The diagnostic we propose will have profound impact both by improving outcomes by providing a means to develop a hypothesis driven first line antimicrobial intervention and likewise by reducing the use of excessive and unnecessary antimicrobials in infants To succeed in this Phase I we have put together a top notch team at HelixBind including experts in assay development application of synthetic nucleic acid analogues in 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 preliminary data and demonstrate the feasibility of our diagnostic To validate our approach we will establish an automated andapos sample to answerandapos diagnostic employing synthetic nucleic acid analogues capable of classifying the most prevalent pathogens directly from human whole blood at clinically relevant load levels Having achieved our Phase I goals in Phase II we will develop a fully integrated prototype and address all issues such as sample injection deployable instrumentation and commercial format PUBLIC HEALTH RELEVANCE Neonatal sepsis is a public health concern and accounts for nearly of all neonatal deaths in the US The key to improving outcomes and reducing the mortality rate is rapid and accurate diagnosis which would enable a more targeted first line antimicrobial intervention We propose to develop the first fully integrated sample to answer diagnostic capable of identifying microbial pathogens bacterial and fungal alike directly from neonatal 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 essentially from the onset of symptoms