The DECIPHER consortium aims to revolutionize the in vitro diagnostic (IVD) point-of-care (POC) field by developing for the first time a true quantitative sample-to-result POC test based on a re-purposed glucose meter, supported by socio-economic system analysis and artificial intelligence (AI)-based models for efficient and effective implementation in the field.
IVD technologies have revolutionized healthcare but because they still depend on a laboratory environment for quantitative results, they remain bound to the traditional centralized healthcare approach. Hence, over the past decade, we have witnessed enormous efforts in the IVD field to bring lab-quality bioassays from the lab to the POC (i.e. clinics, homes, and remote communities). While some qualitative RDTs have reached the market, they still require manual off-chip pre-processing of sample (e.g. metering or dilution). This limits their usage to only trained and experienced operators, therefore preventing their broad implementation as POC devices. Moreover, the COVID-19 pandemic has confronted medical device developers with the many access and practical issues encountered from the end-user side.
The DECIPHER consortium will develop an innovative microfluidic-based DECIPHER patch capable of both biofluids (self-)sampling via hollow microneedles (HMNs) and immediate analysis of this sample on the very same patch in a completely self-powered manner, producing a quantitative result to be read out with a re-purposed glucose meter. Ebola and Lassa viruses are selected as relevant model systems because they are highly contagious with human-to-human transmission, high mortality rate and no vaccine/treatment available, thus having a meaningful potential for new pandemic threats.
To offer such a genuine sample-to-result quantitative POC solution, the DECIPHER value chain will, besides innovations in the field of high-throughput manufacturing processes based on novel photopolymers, microfluidics and HMNs, focus 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. This true interdisciplinarity will be represented by the highly experienced DECIPHER consortium with partners from 3 universities, 5 research institutes, 2 companies and 1 non-governmental organization from 6 countries.
In the DECIPHER project, we aim to contribute to the EU pandemic preparedness program by providing innovative and flexible solutions deployable on short-term upon pandemic threats identification. In this context, flexibility of an IVD infrastructure is key since the source of the next big pandemic cannot be fully predicted. Therefore, the DECIPHER project will use a multifaceted approach, combining quantitative molecular IVD tests with AI-based predictive disease modelling, next to assessing the socio-economic sustainability of this approach.
