NEXOGEN INC — Department of Health and Human Services SBIR Phase II: NICHD

Description

Project Summary Severe sepsis strikes more than a million patients in USA per year and it has been estimated that betweenandpercent of these patients dieexceeding the number of U Sdeaths from prostate cancerbreast cancer and AIDS combinedNeonatal sepsis causes over one million death per year worldwide andtoof infants treated with antibiotics die despite the treatmentwith higher rates occurring in low income countriesRapid and accurate diagnosis of sepsis in NICUsNeonatal Intensive Care Unitsis crucial for implementing a timely treatmentBecause sepsis is a life threatening medical emergency a large proportion of infants receive treatment with potent systemic antibiotics that can adversely lead to destruction of the infant s normal gastrointestinal flora and the risk of becoming colonized with drug resistant microorganismsBlood culturing is used as the gold standard for neonatal diagnosis of sepsishowever the samples are returned afterhrs which often does not provide timely results for neonatal sepsis treatmentMultiple sampling that will increase accuracy of neonatal diagnosis by culturing is minimized because the iatrogenic blood loss may represent up toof total blood in premature babiesNew point of care methods with faster detection time and more accurate to use smaller amounts of sample are urgently neededMolecular DNA based assays have been introduced into the CDC Guidelines for neonatal sepsis diagnosis but current methods lack accuracyneed enrichment of samples and cannot provide the needed multiplexed pathogen identificationHowevertodayof hospitals in USA and world cannot perform DNA analysis and samples are sent to the centralized reference labs with the response time ofdaysThe current point of care diagnostics are mostly based on the real time PCR methods that are limited by the number of colors for detecting multiple organisms or by the high price of the instrument or assay costThis project introduces a new point of carePOCrapid method for DNA RNA diagnostics that will approach total assay turn around time ofmin and that can use very small sample volumesas low asmicroliterscompatible with the neonatal sepsis detectionMultiplexed identification of the neonatal sepsis pathogens is enabled using the microarray approachThe proposed technology will enable a new diagnostic approach that could more rapidly identify neonatal pathogens including hospital associated infections and antibiotic resistant pathogens yielding a more tailored administration of regimen of antibiotics and promoting a judicious use of antibioticsSeveral innovations in manufacturing of cartridge disposable and instrument will bring afold decrease in the cost of instrumentation and cartridges compared to the commercialized platformsThe Phase II project will focus on the platform and neonatal sepsis HAI assay developmenthoweverit is envisioned that the platform will find other broad applications in decentralizedurgent care settings as well as in hospitals Project Narrative Neonatal sepsis is a life threatening medical emergency for infants in the NICUsNeonatal Intensive Care Unitsand causes over one million deathS per year worldwideStandard culturing method for diagnosis of sepsis requires up tohrs that is often too late for implementing an adequate antibiotic treatmentespecially when trying to minimize unnecessary antibiotic treatments and or impact the development of antibiotic resistant bacterial strainsStandard methods require a relatively large blood sample volumes causing significant iatrogenic blood losses in neonatesthat limit the repetition of the samplingthat would improve the accuracy and prevent false positives due to bacterial contamination during samplingThis project brings a new DNA based point of care method withminutes sample to answer timeoffering very small sample volumesas low asmicroliterscompatible with the neonatal sepsis detection and a highly multiplexed detection of both sepsis and antibiotic resistant pathogens in neonatal infectionsThe platform will find broad applications in the point of care diagnostics of emergentpandemic and infectious diseases as well as its implementation in decentralized settings such as urgent care clinics and emergency rooms as well as in hospitals