Concept

2D-BioPAD aims to introduce a fast and cost-effective, non-invasive, reliable, digitally and graphene enabled Point-of-Care (PoC) in-vitro diagnostics (IVD) system for supporting the early diagnosis and progression monitoring of Alzheimer’s Disease (AD) directly at primary healthcare settings. To achieve this, and tackle the scientific challenge, the technological and market gap of PoC IVD for AD, 2D-BioPAD leverages the unique properties of 2D materials, such as graphene and its derivatives.

Towards that direction, 2D-BioPAD goes beyond the state-of-the- art of its 2D Materials’ pioneer consortium to deliver a graphene-based PoC IVD system that will

(i) introduce a versatile surface chemistry that combines nano and DNA technologies towards improved biocompatibility, stability, as well as high sensitivity and specificity for enhanced (bio-)sensing;

(ii) be able to reliably identify and quantify in real-time and simultaneously up to 5 AD biomarkers in blood samples effectively supporting healthcare professionals in early diagnosis;

(iii) offer an easy to use and understand digital interface with key metrics and insights regarding the measured results; and

(iv) employ Artificial Intelligence (AI) to improve the overall system implementation.

The 2D-BioPAD system and an impact will be demonstrated in 3 clinical centers in Europe (Finland, Greece, and Germany) under two clinical pilot studies. In every step, and from the very beginning, 2D-BioPAD will go beyond current norms and involve a wide range of stakeholders, starting from the clinic itself, and led by industrial partners, to identify the essential safety and ethical-by-design principles and guidelines that can accelerate uptake at primary healthcare settings and maximize acceptance and impact to both physical and digital supply chains.

Concept & Objectives

  • Introduce an affordable PoC IVD system for early AD diagnosis in primary healthcare settings.
  • Utilise CRM-free graphene sensors to enhance diagnostics and disease progression monitoring.
  • Prioritise safety, ethics, and regulatory compliance
  • Conduct proof-of-concept clinical pilots to validate the approach
  • Enhance Europe’s industrial standing in 2D materials for biomedical devices, aligning with the Graphene Flagship Initiative’s (GFI) goals
  • Foster synergies, knowledge exchange, and sustainable result exploitation