Project Grant 2304069

SBIR PHASE I: AUTOMATED ONE-HOUR TESTING FOR BACTEREMIA AND ANTIBIOTIC SENSITIVITY -THE BROADER IMPACT/COMMERCIAL POTENTIAL OF THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE I PROJECT IS TO IMPROVE EARLY DETECTION AND CLINICAL MANAGEMENT OF BACTEREMIA IN PATIENTS SUSPECTED OF BACTERIAL SEPSIS. OVER 250,000 PATIENTS DIE OF SEPSIS EACH YEAR IN THE U.S., WHICH RESULTS IN HOSPITALIZATION COSTS EXCEEDING $20 BILLION. A SEPSIS PATIENT?S RISK OF DEATH HAS BEEN DEMONSTRATED TO INCREASE BY 4-7% PER HOUR, WHERE TIMELY ADMINISTRATION OF APPROPRIATE ANTIBIOTICS IS EXPECTED TO IMPROVE PATIENT SURVIVAL. UNFORTUNATELY, THE STANDARD OF CARE APPROACH FOR DETERMINING ANTIBIOTIC SUSCEPTIBILITY REQUIRES OVERNIGHT CULTURING THAT CAN TAKE A DAY OR MORE. CURRENTLY, BROAD SPECTRUM ANTIBIOTICS ARE ADMINISTERED WITHIN THE FIRST HOUR OF TREATMENT WITH THE HOPE THAT THE PATHOGEN WILL BE SUSCEPTIBLE, WHILE WAITING FOR ANTIBIOTIC SUSCEPTIBILITY RESULTS. THE GROWING LANDSCAPE OF ANTIBIOTIC RESISTANCE SEVERELY UNDERMINES THE EFFICACY OF THE STANDARD APPROACH, AS MANY PATHOGENS ARE INCREASINGLY RESISTANT TO BROAD-SPECTRUM ANTIBIOTICS. THIS PROJECT SEEKS TO ADVANCE DEVELOPMENT OF A NOVEL OPTICAL APPROACH FOR DETERMINING ANTIBIOTIC SUSCEPTIBILITY RESULTS WITHIN 1 HOUR TO SUPPORT THE USE OF APPROPRIATE ANTIBIOTICS, WHICH HAS SIGNIFICANT POTENTIAL TO IMPROVE PATIENT MORTALITY OUTCOMES AND REDUCE HOSPITALIZATION COSTS. THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE I PROJECT INVOLVES AN OPTICAL TECHNOLOGY FOR THE RAPID DETERMINATION OF ANTIBIOTIC SUSCEPTIBILITY RESULTS FROM A BLOOD SAMPLE FOR PATIENTS SUSPECTED OF BACTEREMIA. THE PRODUCT USES AN ASSAY FOR ASSESSMENT OF BACTERIAL METABOLISM, WHERE A BLOOD SPECIMEN MAY BE CULTURED WITH AND WITHOUT ANTIBIOTICS TO DETERMINE ANTIBIOTIC SUSCEPTIBILITY. ADVANCEMENTS IN THE ASSAY AND MICROFLUIDICS ENABLE DELIVERY OF ANTIBIOTIC SUSCEPTIBILITY RESULTS WITHIN ONE HOUR. THIS TIMEFRAME WOULD ENABLE CLINICIANS TO USE ANTIBIOTICS THAT ARE TARGETED TO THE PATIENT?S SPECIFIC BACTERIAL PATHOGEN SIGNIFICANTLY EARLIER, WHICH IS EXPECTED TO IMPROVE PATIENT OUTCOMES. THE GOAL OF THIS PROJECT WILL BE TO RIGOROUSLY DEMONSTRATE THE PROOF-OF-CONCEPT AND REPRODUCIBILITY OF THE TECHNOLOGY. THIS AWARD REFLECTS NSF'S STATUTORY MISSION AND HAS BEEN DEEMED WORTHY OF SUPPORT THROUGH EVALUATION USING THE FOUNDATION'S INTELLECTUAL MERIT AND BROADER IMPACTS REVIEW CRITERIA.