GINER INC — Department of Health and Human Services SBIR Phase II: ODCDC

Description

Multidrug resistant organisms MDROs are responsible for over million hospitalization cases and deaths annually in the U S The lack of effective antibiotic therapies against resistant pathogens leads to increased mortality increased hospital length of stay and excessive direct healthcare costs as high as $ billion yr Monitoring the MDROs in the gastrointestinal tract is therefore critical as early warning for emerging infections identifying resistance patterns and informing future clinical decisions The goal of this Phase II project is to design demonstrate a clinical assay based on an electrochemical DNA detection platform developed in Phase I The Phase II assay will include detection of up to MDRO genes utilizing a multiplexed operation A clinical demonstration study will be performed to demonstrate the predictive capability of the assay in detecting gut microbiome disruption and MDRO acquisition persistence in pediatric patients The assay results will be benchmarked to standard diagnostic techniques During Phase II several investigators with expertise in advanced microbiome therapeutics such as fecal microbiota transplantation will be engaged to design a future collaborative clinical study Phase IIB III that would utilize Giner s instrument to Identify high risk patients for MDRO transmission Improve treatment for patients with MDRO gut infections and Assist advanced microbiome therapeutics