Project Grant R43FD007315

LATERAL FLOW ARRAY FOR UNDECLARED FOOD ALLERGENS - PROJECT SUMMARY AT LEAST 15 MILLION AMERICANS AND 5% OF CHILDREN UNDER 5 YEARS OLD SUFFER FROM FOOD ALLERGIES. MANY COUNTRIES NOW HAVE MANDATORY FOOD LABELING REQUIREMENTS FOR COMMON ALLERGENS THAT ARE INTENTIONALLY ADDED TO FOOD PRODUCTS. UNFORTUNATELY, THERE ARE AT LEAST 170 KNOWN FOOD ALLERGENS, AND UNDECLARED FOOD ALLERGENS CAN ACCIDENTALLY CONTAMINATE A PRODUCT THROUGH SHARED PROCESSING EQUIPMENT, DURING TRANSPORT, IN STORAGE, OR BECAUSE OF FRAUD AND TERRORISM, AND RESULT IN ADVERSE REACTIONS OR FATALITIES. THE INDUSTRY CURRENTLY TESTS FOR UNDECLARED FOOD ALLERGENS WITH SINGLE-TARGET ELISAS, HIGH-RESOLUTION MASS SPECTROMETRY, OR RELATED METHODS. FOOD PROCESSORS AND TESTING LABORATORIES THEREFORE CONTINUOUSLY REQUEST AND NEED A SENSITIVE, SPECIFIC, AND EASY-TO-USE MULTI-ALLERGEN TEST TO MINIMIZE CONSUMER HEALTH RISK, AND THE POTENTIAL FOR FOOD RECALLS. THE OBJECTIVE OF THIS PROJECT IS TO FILL THIS IMPORTANT PUBLIC HEALTH TECHNOLOGY GAP BY INCORPORATING BIOFRONT'S PROPRIETARY MONOCLONAL ALLERGEN ANTIBODIES WITHIN AKONNI'S FDA-CLEARED DX2000 LATERAL FLOW MICROARRAY (LFA) PLATFORM, AND VALIDATING SYSTEM PERFORMANCE WITHIN THE CONTEXT OF MICROBAC'S ISO 17025-COMPLIANT FOOD SAFETY TESTING SERVICE. IN PHASE 1, WE WILL VERIFY THE FUNCTIONALITY AND SPECIFICITY OF BIOFRONT MONOCLONAL ANTIBODIES IN AKONNI'S LATERAL FLOW ARRAY; ESTABLISH A TEST METHOD THAT ACHIEVES A 1 PPM LIMIT OF DETECTION FOR EACH OF THE TARGET ALLERGENS; AND DEMONSTRATE FEASIBILITY OF THE TEST WITH PROCESSED FOOD EXTRACTS. THESE RESULTS WILL LAY THE FOUNDATION FOR A PHASE 2 PROJECT, WHERE WE WILL EXPAND THE TEST FOR ALL REMAINING HIGH-PRIORITY ALLERGENS; TRANSFER MANUFACTURING AND PACKAGING TO AKONNI'S ISO13485-COMPLIANT PRODUCTION LINES; USE THE PLATFORM TO DEVELOP AN AOAC-APPROVED ANALYSIS METHOD AT MICROBAC; VALIDATE THE SYSTEM FOR MICROBAC'S TOP 10 FOODS/TESTS; AND FINISH ALL OTHER ACTIVITIES REQUIRED TO COMMERCIALIZE THE SYSTEM AND TESTING/ANALYSIS SERVICE(S). COMPLETING THESE MILESTONES WILL ESTABLISH A NEW CLASS OF MULTIPLEXED, COMPONENT-RESOLVED ALLERGEN DETECTION PRODUCTS AND FOOD TESTING SERVICES THAT ARE EXPECTED TO IMPROVE CONSUMER/PUBLIC SAFETY, AND PROVIDE PRODUCERS AN AFFORDABLE MECHANISM TO COMPLY WITH ZERO-TOLERANCE FOOD SAFETY POLICIES.