BIOSENSING DEVICES FOR IN VITRO DIAGNOSTICS

THE SENS4IVD PROPOSAL AIMS AT DESIGNING IN VITRO DIAGNOSTIC (IVD) TESTS TO RELIABLY IDENTIFY THE NATURE AND CHARACTERISTICS OF A DISEASE IN THE EARLY STAGE, FOCUSING ON QUANTIFYING BIOMARKERS OF DIFFERENT NATURE, ENVISIONING PRIMARY APPLICATIONS IN HEALTHCARE. THIS WILL BE ACHIEVED BY DEVELOPING AN INNOVATIVE IVD DEVICE, COMBINING MAGNETIC ACTUATION AND ELECTROCHEMICAL BIOSENSING IN A PORTABLE READER OPERATED BY BATTERIES. THE LONG-TERM VISION OF THE SENS4IVD APPROACH IS BASED ON AN AGNOSTIC PLATFORM FOR THE QUANTIFICATION OF ALL TYPES OF BIOMARKERS, REGARDLESS OF THEIR NATURE, WHICH CAN BE EASILY SWITCHED TO EMERGING CHALLENGES. SENS4IVD WILL DRASTICALLY SHORTEN THE RESULTS TIME, BY QUANTIFYING PROTEINS, EXOSOMES, TRANSCRIPTS, DNA, OR MIRNA BIOMARKERS DOWN TO A LOW CONCENTRATION RANGE IN A SIMPLIFY ANALYTICAL PROCEDURE FOR THE END-USER. SUCH A IVD TEST CAN BE USED BOTH IN LOW RESOURCE SETTINGS WHERE HIGH-QUALITY GOLD-STANDARD LABORATORY TESTS ARE NOT AVAILABLE, AND IN HIGH-INCOME COUNTRIES TO DRAMATICALLY IMPROVE TURNAROUND TIMES FOR RESULTS TO REDUCE COSTS. THE OUTCOMES ACHIEVED BY SENS4IVD WILL ENABLE DECISION-MAKING OF CLINICIANS TOWARD A PERSONALIZED MEDICINE, FOR AN ACCURATE DIAGNOSIS IN SOME INSTANCES, OR THE MONITORING OF DISEASE TREATMENT IN OTHER APPLICATIONS, THEREBY IMPROVING THE QUALITY OF LIFE AND REDUCING COSTS IN THE HEALTHCARE SYSTEMS. THE VALIDATION OF THE PROOF OF CONCEPT IS ENVISAGED WITH A BROAD RANGE OF TARGETS IDENTIFIED BY KEY OPINION LEADERS IN EMERGING INFECTION DISEASES, IMMUNOLOGY, AND CANCER, TAKING AS REFERENCE COMMUNICABLE DISEASES (BY MONITORING THE CELLULAR IMMUNE RESPONSE AND THE MOLECULAR SIGNATURE IN EXOSOMES RELEASED DUE TO INFECTION), NON-COMMUNICABLE DISEASES (SUCH AS BREAST CANCER), AND BACTERIA AFFECTING WATER SOURCES. A COHERENT BUSINESS-FOCUSED ANALYSIS OF RESEARCH AND INNOVATION BOTTLENECKS AND OPPORTUNITIES TO FURTHER SOCIETAL CHALLENGES RELATED WITH HEALTH AND WELLBEING WILL BE ASSESSED. THIS, IN COMBINATION WITH A VALORIZATION AND COMMERCIALIZATION PLAN, WILL PAVE THE WAY FOR FUTURE LARGE-SCALE IMPLEMENTATION OF THE SENS4IVD PROTOTYPES.