DECIPHER
The DECIPHER consortium aims to revolutionize the field of in vitro diagnostics (IVD) at the point-of-care (POC) by developing for the first time a true quantitative POC test from sample to result based on a repurposed glucose meter, supported by socio-economic systems analysis and artificial intelligence (AI)-based models for efficient and effective implementation in the field.
Project Partners
- Polymer Competence Center Leoben (PCCL)
- KU Leuven (KUL), Coordinator
- Joanneum Research (JR)
- Montanuniversität Leoben (MUL)
- Institute of Tropical Medicine Antwerp (ITM)
- Carnegie Mellon University (CMU)
- EPCON (EPC)
- Temicon (TEM)
- Medicins Sans Frontieres (MSF)
- Center National de Formation et de Recherche en Santé Rurale de Maferinyah (CNFRSR)
- Institut National de Recherche Biomedicale (INRB)
Motivation and Goals
The DECIPHER consortium develops an innovative microfluidic DECIPHER patch that allows both (self-)sampling of biofluids via hollow microneedles (HMNs) and immediate analysis of this sample on the same patch with its own power supply, providing a quantitative result that can be read with a repurposed glucose meter.
The DECIPHER project focuses on viral hemorrhagic fevers (VHF), i.e. Ebola and Lassa viruses, as these viruses are:
- Highly contagious and transmissible from person to person
- Life-threatening, with a high mortality rate
- Early diagnosis in the POC is difficult
- No effective drugs or vaccines
- High prevalence in low- and middle-income countries, which represent a reservoir for several zoonotic diseases with pandemic potential
DECIPHER contributes to the EU's pandemic preparedness program by providing innovative and flexible solutions that can be used at short notice to identify pandemic threats. In this context, the flexibility of an IVD infrastructure is crucial as the source of the next major pandemic cannot be fully predicted. Therefore, the DECIPHER project will take a multi-layered approach combining quantitative molecular IVD testing with AI-based predictive disease modeling to subsequently assess the socio-economic sustainability of this approach.
For this reason, DECIPHER has a cross-cutting character, addressing various complementary growth markets, working with academic, industrial and societal stakeholders and addressing several EU policy priorities as well as the WHO Sustainable Development Goals:
- Supporting the fight against epidemics of neglected tropical diseases with novel IVD solutions (timely diagnosis at the POC is key to prevent the spread of pandemics)
- Ensuring universal access to quality essential health services with a device for POC settings
- Develop and train health workers in developing countries, as demonstrated by the involvement of CNFRSR (Guinea), INRB (DRC) and MSF (with VHF projects in Nigeria)
- Strengthening the capacity of all countries for early warning, risk mitigation and management of national and global health risks by providing new tools for rapid medical decision-making
- Strengthening and promoting the social and economic inclusion of all people
Main Goals
The DECIPHER consortium revolutionizes the IVD POC field by developing for the first time a true quantitative sample-to-result POC test. This will be achieved by building a DECIPHER patch capable of:
- Biofluids (self-)sampling via HMNs
- Immediate analysis of this sample on the very same patch
To achieve this, DECIPHER implements:
1. Molecular bioassays
Reverse Transcription Recombinase Polymerase Amplification (RT-RPA) bioassays are investigated based on innovative DNA nanotechnology, for achieving superb specificity and sensitivity for viral hemorrhagic fever (VHF) management (Ebola and Lassa viruses). This is crucial to identify infected individuals at an earlier stage to prevent the spread of the outbreak and to distinguish a high from a low viral load, which in turn facilitates the treatment of patients.
2. Quantitative readout
The quantitative readout is done by a (repurposed) ubiquitous, well-accepted, cost-effective and easy-to-use glucose meter. Thus, the DECIPHER quantitative patch will diversify and accelerate the global diagnostic research to tackle cross-border health threats and strengthen the EU's current leading role in research and development.
3. High-troughput microfabrication
High-throughput roll-to-roll nanoimprint technology with novel biocompatible photopolymers is employed to establish a high throughput production line for DECIPHER patches (microfluidics and HMNs).
4. AI-based socio-economic system analysis
Socio-economic systems analysis and an AI-powered tool are used to provide new insights for decision support in the introduction and scale-up of new IVDs. This allows dynamic allocation of resources depending on disease risk, targets set and available capacity, enabling more effective and efficient implementation on the ground.
5. Life cycle assessment
Life cycle assessment studies are carried out on the production steps and the impact of different use and end-of-life scenarios of the DECIPHER patch, taking into account the dynamics of the socio-economic system.
Objectives and Approach
In order to provide such a genuine quantitative POC solution from sample to result, the DECIPHER value chain focuses on (1) novel quantitative molecular bioassays, (2) analytical and clinical validation (both retrospective and prospective), (3) AI-based models, (4) socio-economic/systems analysis and (5) life cycle assessment, in addition to innovations in high-throughput manufacturing processes based on novel photopolymers, microfluidics and HMNs. This true interdisciplinarity is represented by the highly experienced DECIPHER consortium with partners from three universities, five research institutes, two companies and one non-governmental organization from six countries. The project is coordinated by KU Leuven.
“The DECIPHER consortium is interdisciplinary and brings together many experts along the value chain of point-of-care in-vitro diagnostics. The topic is highly relevant to society, as decentralized diagnostics in combination with AI-based predictive disease modeling will become increasingly important in the future to prevent the outbreak of new pandemics. Within the project, PCCL is developing stimuli-responsive photopolymers that can be micro-structured using nanoimprint lithography and thus serve as the core material for the microfluidic patch.”
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Funding Body
Funded by the European Union (grant agreement Nº 101137242). Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the granting authority European Union’s Horizon Europe research and innovation programme. Neither the European Union nor the granting authority can be held responsible for them.
