Cooperative Agreement 2309437

SBIR PHASE II: POINT-OF-CARE ELECTROCHEMICAL PLATFORM FOR THE RAPID DETECTION OF DRUG TOXICITY -THE BROADER IMPACT/COMMERCIAL POTENTIAL OF THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE II PROJECT IS THAT POISONING BY DRUGS OF ABUSE AFFECTS ALMOST 3 MILLION PEOPLE ANNUALLY AND IS THE LEADING CAUSE OF INJURY-RELATED DEATH IN THE UNITED STATES. THERE WERE 100,306 OPIOID OVERDOSE DEATHS IN THE US IN 2021, THE MAJORITY OF WHICH WERE DUE TO FENTANYL POISONING. SCREENING PATIENTS FOR TOXIC DRUG LEVELS CURRENTLY REQUIRES SPECIMEN PROCESSING IN HOSPITAL LABORATORIES, TAKING HOURS TO OBTAIN RESULTS. IMMEDIATE, ACCURATE DETECTION OF FENTANYL POISONING AT THE POINT OF CONTACT, IN THE AMBULANCE OR EMERGENCY ROOM, WILL CREATE A NEW PARADIGM FOR THE RAPID DIAGNOSIS AND IMPROVED CARE OF POISONED PATIENTS AND SAVE LIVES. THE SBIR PHASE II PROJECT OUTCOME WILL BE AN FDA-READY, HAND-HELD SENSOR DEVICE CAPABLE OF ACCURATELY MEASURING FENTANYL AND OTHER DRUG LEVELS FROM A DROP OF BLOOD OR SALIVA WITHIN MINUTES. THE PLATFORM DEVICE USES DISPOSABLE SENSOR STRIPS AND IS LOW COST AND SCALABLE, PERMITTING BROAD COMMERCIAL ADOPTION. FUTURE POTENTIAL APPLICATIONS FOR THIS POINT OF CARE TESTING TECHNOLOGY INCLUDE ITS USE BY PHYSICIANS FOR OFFICE-BASED SCREENING FOR THERAPEUTIC DRUG MONITORING TO CONFIRM COMPLIANCE AND OPTIMIZE MEDICATION USE AND EFFICACY. THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE II PROJECT WILL TEST AN INNOVATIVE, PROTOTYPE BIOSENSOR DEVICE THAT PROVIDES THE USER WITH REAL TIME, ACCURATE DETECTION AND QUANTIFICATION OF TOXIC DRUG LEVELS IN THE BLOOD USING INEXPENSIVE, DISPOSABLE TEST STRIPS SIMILAR TO A DIABETES GLUCOMETER. THE RESEARCH TO BE PERFORMED IN THE PHASE II PROJECT WILL UTILIZE ELECTROANALYTICAL METHODS TO OPTIMIZE THE PERFORMANCE OF THE SENSOR TO IMPROVE ITS SELECTIVITY AND LOWEST LIMIT OF DETECTION FOR FENTANYL AND OTHER DRUGS COMMONLY ASSOCIATED WITH POISONING. ADDITIONAL METHODS, SENSOR COATINGS, AND TESTING CONDITIONS WILL BE USED TO DETECT TOTAL-DRUG LEVELS IN THE BLOOD AND DEMONSTRATE THAT THE BIOSENSOR CAN DISTINGUISH BETWEEN CLASSES OF MEDICATIONS AND POTENTIAL CLINICAL INTERFERENTS AS WELL AS SHOW EQUIVALENT RESULTS TO CURRENT CLINICAL LABORATORY METHODS. THE BIOSENSOR WILL DETECT DRUGS OF OVERDOSE AND OTHER MEDICATIONS BELOW THERAPEUTIC LEVELS, WITHOUT SPECIMEN PROCESSING. PILOT LARGE ANIMAL STUDIES WILL SEEK TO VALIDATE THE CORRELATION OF DRUG LEVELS IN THE BLOOD WITH SALIVA TO ESTABLISH A PROOF OF CONCEPT FOR RAPID SUBLINGUAL TESTING FOR DRUG TOXICITY. 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.