Our approach

Centralized strategy

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.

Decentralized strategy

However, there is a mounting body of evidence that this practice does not address the current worldwide trends and expectations on how to manage and treat diseases. This has resulted in the growing urge to move towards a decentralized approach, expecting to bring time- and cost-benefit for patients, doctors, and the healthcare system in general. 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).

Traditional RDT

While lab-on-a-chip (LoC) technologies, enabling complex fluid manipulations for miniaturized and automated bioassays on a chip, have long promised to disrupt the IVD market, clinically relevant solutions have so far failed to make a significant impact and reach the market. This can be attributed to the complexity of integration/operation, high cost, off-chip sample preparation, to name a few. However, some qualitative RDTs have reached the market but 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. All these shortcomings were in the spotlight during the COVID-19 pandemic, which has been perceived as a real game-changer in the field of IVD POC. While this pandemic provided many medical device developers with the opportunity to test their novel POC systems in the field already in an early phase, it also confronted them with the many access and practical issues encountered from the end-user side.

Hence, the DECIPHER consortium aims to revolutionize 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:

To achieve this, we will implement:

Molecular bioassays

Reverse Transcription Recombinase Polymerase Amplification (RT-RPA) bioassays will be developed based on innovative DNA nanotechnology, for achieving superb specificity and sensitivity for viral hemorrhagic fever (VHF) management (Ebola and Lassa viruses). This will be essential to identify infected people at an earlier stage to prevent even sooner the spread of the outbreak, next to distinguishing high from low viral loads, thus helping in the patient treatment.

Quantitative readout

A (re-purposed) ubiquitous, well-accepted, inexpensive, and easy-to-use glucose meter will be used for quantitative readout. As such, the quantitative DECIPHER patch will diversify and accelerate the global diagnostic research and development pipeline to tackle cross-border health threats, next to strengthening the current leading role of the EU in research and development.

High-throughput microfabrication

High-throughput microfabrication technology with novel biocompatible photopolymers will be employed with the final aim to establish a high throughput production line for DECIPHER patches (microfluidics and HMNs).

AI-based socio-economic system analysis

Socio-economic system analysis and an AI-based tool will be applied to generate new insights for decision support related to the introduction and scale-up of novel IVD. This will allow academic and field partners to dynamically allocate resources in function of disease risk, set targets and available capacity and as such enable a more effective and efficient implementation in the field.

Life cycle assessment

Life cycle assessment studies will be performed with respect to the production steps as well as the impact of different use and end-of-life scenarios of the DECIPHER patch, in alignment with the socio-economic system dynamics.

By relying on the long-lasting expertise of our partners in affected endemic countries continuously dealing with VHF, we will finally perform an in depth analytical and clinical validation.

DECIPHER sampling module

The sampling module will initially be validated using benchtop models, such as artificial tissues, followed by using in vivo animal models and ultimately performing blood sampling trials on healthy volunteers.

DECIPHER bioassay modules

The bioassay module will be validated with both biobanked plasma samples (retrospective clinical validation) as well as with blood collected from patients (prospective clinical validation), next to validation of the DECIPHER patch in a controlled clinical setting.