DECIPHER · Decentralized microfluidic in vitro diagnostic patch for pandemic control

In vitro diagnostic (IVD) technologies have revolutionized healthcare, yet remain confined to the laboratories. This traditional approach massively failed to manage viral outbreak during the COVID-19 pandemic because it lacked quick and cost-effective diagnosis. Moreover, an urgent need was evident for bringing quantitative lab-quality diagnosis to the hands of end users (i.e., point-of-care, POC). Despite high expectations from Lab-on-Chip technologies, they failed so far to disrupt the IVD market due to their complexity, high cost, off-chip sample preparation, poor scalability, to mention a few. The DECIPHER consortium aims to revolutionize the POC IVD field by developing 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 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 meaningful potential for new pandemic threats. To offer such a genuine sample-to-result quantitative POC solution, the DECIPHER value chain, from lab to market, will cover: (1) investigation of high-throughput manufacturing processes with (2) novel polymers, innovations in the fields of (3) microfluidics, (4) HMNs and (5) quantitative molecular bioassays, (6) DECIPHER patch analytical and clinical validation (both retrospective and prospective), as well as (7) AI-based models, (8) socio-economic/systems analysis and (9) life cycle assessment of DECIPHER patch. This true interdisciplinarity will be represented by highly experienced DECIPHER consortium with partners from 3 universities, 5 research institutes, 1 SME, 1 large company and 1 non-governmental organization from 6 countries.