Project Grant R43DK136652

POINT-OF-CARE ASSAY FOR TYPE 1 DIABETES DIAGNOSIS AND PROGNOSTICATION - PROJECT SUMMARY TYPE 1 DIABETES (T1D) AFFECTS ~1.5 MILLION PEOPLE IN THE US AND IS THE SECOND MOST COMMON CHRONIC ILLNESS IN CHILDREN. T1D OCCURS AS THE RESULT OF A MISTAKEN ATTACK BY THE IMMUNE SYSTEM ON THE PANCREAS. AUTOANTIBODIES TO PANCREATIC ISLET ANTIGENS, A BYPRODUCT OF T1D AUTOIMMUNITY, ARE WELL-VALIDATED BIOMARKERS FOR T1D. THEY ARE PRESENT IN BLOOD LONG BEFORE THE DEVELOPMENT OF CLINICAL T1D SYMPTOMS, AND SERVE AS IDEAL BIOMARKERS FOR THE EARLY DIAGNOSIS OF T1D. LARGE CLINICAL TRIALS HAVE PROVEN THAT SCREENING CHILDREN FOR T1D AUTOANTIBODIES IS AN EFFECTIVE WAY TO REDUCE LIFE-THREATENING EPISODES OF KETOACIDOSIS. AND, THESE PATIENTS CAN BE TREATED WITH A NEW DRUG (TEPLIZUMAB), WHICH DELAYS THE ONSET OF INSULIN DEPENDENCE BY AN AVERAGE OF 2.8 YEARS. THESE RECENT DEVELOPMENTS DEMONSTRATE THE OBVIOUS MEDICAL AND SOCIAL BENEFITS OF POPULATION-LEVEL SCREENING OF CHILDREN FOR T1D AUTOANTIBODIES, BUT THIS WORTHY GOAL WOULD REQUIRE MANY MILLIONS OF T1D AUTOANTIBODY TESTS TO BE PERFORMED EACH YEAR IN THE US ALONE. THIS FEAT IS OUT OF REACH WITH CURRENT TESTING TECHNOLOGY, WHICH IS SLOW, EXPENSIVE, AND REQUIRES CENTRALIZED LABORATORY FACILITIES. THE ONLY POSSIBLE SOLUTION TO THIS PROBLEM IS A POINT-OF-CARE T1D AUTOANTIBODY TEST, YET POINT-OF-CARE TESTS TO DATE HAVE LACKED THE NECESSARY ANALYTICAL PERFORMANCE. IN THIS PHASE I PROJECT, ELECTRONIC BIOSCIENCES, INC. WILL DEVELOP A T1D ASSAY, BASED ON THE LATEST DEVELOPMENTS IN NANOPORE TECHNOLOGY, TO RAPIDLY DETECT A PANEL OF THE MOST CLINICALLY RELEVANT T1D AUTOANTIBODIES IN A POINT-OF- CARE FORMAT. A KEY ASPECT OF THE FIND TECHNOLOGY IS ITS CAPACITY TO BE HIGHLY MULTIPLEXED, WHICH WILL ALLOW NEW T1D AUTOANTIBODY BIOMARKERS TO BE ADDED TO THE PANEL AS THEY ARE DISCOVERED AND VALIDATED, WHICH WILL FURTHER IMPROVE THE DIAGNOSTIC AND PROGNOSTIC CAPABILITY OF THE TEST. THE PROPOSED LOW COST, HIGH PERFORMANCE, T1D TEST IS THE IDEAL SOLUTION FOR POPULATION-LEVEL T1D SCREENING.