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 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 optimisation 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 commercialisation of innovative POCT products and systems
TheraEDGE consists of three multidisciplinary platforms:
- a core Lab-on-a-Chip supporting multi-marker assays 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.
Main results, benefits and impacts
The TheraEDGE system is conceived as a solution to overcome the current hurdles in the use of POCT in Primary Care.
The objectives of the project can be summarised as follows:
- Objective #1: to address a highly relevant clinical need
TheraEDGE postulates that adding a theranostics dimension to POCT systems will increase their applicability in Primary Care settings, where clinical acts are often carried out in their entirety by one individual doctor within a single, short patient encounter.
- Objective #2: to achieve faster clinical turnaround
The aim is to prove that in the absence of amplification steps SMD-based assays can enable clinical decision-making in less than 20 minutes from sample extraction to result delivery.
- Objective #3: to use small sample volumes
The introduction of a lab-on-a-chip biosensor accepting a small sample swab and integrating at large scale all the assay procedure steps will enable general practitioners and nurses to use small-volume samples quickly obtained from the patient.
- Objective #4: to improve analytical performance
Single Molecule Detection techniques offers the prospect of higher sensitivity, higher specificity and lower coefficient of variation than alternative analytical techniques typically used at the Point of Care.
- Objective #5: to improve usability and robustness
TheraEDGE aims at promoting the development of standard analytical and operational platforms, which will be demonstrated for the LRTI clinical case but will be developed for broader use, including the detection of nucleic acids (pathogen genomes), proteins and metabolites.
- Objective #6: to provide economic systems
The total TheraEDGE cost per test will essentially be driven by the cost of the disposables, which shall be minimised by the use of proper "design-for-manufacturability" techniques, selection of materials, manufacturing processes, etc.
The three most important conclusions in this first three years of the project can be summarised as follows:
- The sensitivity of the proposed detection system for TheraEDGE is compatible with the detection requirements of non-amplified samples collected with the protocols of primary care. The short turnaround times of 30 minutes seem feasible with the present alternative.
- Both the instrument and cartridge prototypes are in-line to meet the usability requirements defined by the CLIA-waived standards of the FDA, which would also be applicable for the European markets. To an equal level of importance is the quality of results offered by TheraEDGE, which shall be comparable to that of central laboratories.
- In terms of commercial feasibility, one can present the following conclusions:
- A significant share of the success of TheraEDGE will depend on achieving a CLIA-waived status to gain access to all potential selling points.
- Independent of the commercialisation strategy, the cost per test should be similar to those assays already reimbursed by public healthcare systems.
- An important competitive advantage of TheraEDGE is its multianalyte capability, which shall be assessed when considering pre-industrial development phases and definition of commercial assay menus.
This field will be completed by the submitter when the lessons learnt have been identified and understood.Scope: International