TheraEDGE is an industry-driven effort to accelerate the adoption of theranostics applications in Primary Care by pushing Point of Care Test (POCT) technology far beyond its current state-of-the-art and by delivering clinical, analytical and operational breakthroughs.TheraEDGE is built around the high-incidence clinical case of early-diagnosing lower respiratory tract infections in Primary Care. Simultaneous testing for different pathogens and their antibiotic resistance will have a huge European impact:•better clinical outcomes and standards of care through more effective and timely diagnosis and treatment•improved health economics through optimization of antibiotics prescription, infection control practices and reduction of clinical visits or hospital stays•substantial business for the In Vitro Diagnostics industry through the standardisation and commercialization of innovative POCT products and systemsTheraEDGE consists of three multidisciplinary platforms:•a core Lab-On-a-Chip supporting multi-marker assays and using Single Molecule Detection (SMD) as an alternative to PCR-based molecular diagnostics. SMD removes the need for amplification and has the potential to become a key enabler for Nucleic Acid Testing at the Point of Care by providing less complex, faster, more sensitive and more specific assays•an architecture that provides Plug and Play semantic interoperability and creates opportunities for the standardisation of POCT instruments and information systems, offering radical usability, robustness and vendor interoperability improvements. Practitioners will be able to run out-of-the-box multiple compliant devices from one single PDA-based operator interface•a set of applications built on a convergent ITC platform that supports General Practitioners in their patient management and clinical decision-making, and provides therapeutic services for patient education and compliance monitoring in order to fight antibiotic misuse and abuse.