MEMoRiEx. Device for Molecular Evaluation and Monitoring of Risk of Alzheimer’s disease based on Exosomes

The product relies on an in vitro diagnostic (IVD) platform, developed by BioEclosion, featuring a disposable cartridge and a reader. This innovative platform integrates tailor-designed probes to capture brain-derived exosomes from plasma and to detect on their surface the protein BACE-1, an enzyme that cleaves the amyloid precursor protein, leading to the formation of β-amyloid peptides. Insoluble forms of β-amyloid peptides are the primary components of amyloid plaques, a hallmark of Alzheimer’s disease. The platform works with magnetic actuation and an electrochemical biosensor in a portable, battery-operated reader.  The long-term vision of the MEMoRiEx consortium relies on an IVD platform capable of stratifying cognitively impaired patients, identifying those who are more at risk of developing AD.  Current diagnostic tools for AD rely on clinical and neuropsychological assessments, imaging techniques like positron emission tomography and magnetic resonance imaging, and cerebrospinal fluid biomarker analysis. These methods are costly, invasive, and often inaccessible, especially in low- and middle-income countries. These drawbacks highly limit early diagnosis, which is critical for effective treatment, particularly for emerging disease-modifying therapies. For that, there is a pressing need for novel, accessible biomarkers, particularly in plasma. Exosome-based diagnostic tests have emerged as a promising solution in this sense, offering minimally invasive blood-based approaches to detect AD-related changes, holding the potential for improving diagnostic accuracy, patient compliance, and affordability, making them ideal for early detection and point-of-care applications.  The MEMoRiEx proposal has significant utility both in low-income countries to reduce the diagnostic gap where high-quality gold-standard laboratory tests are unavailable and in high-income countries to significantly improve result turnaround times and dramatically improve patient compliance, reducing costs and allowing timely interventions, implementing precision medicine. The MEMoRiEx outcomes will enable decision-makers to implement Alzheimer’s dementia monitoring at a global level, improving human health and alleviating the economic consequences for patients, families, and the overall health system. This three year project is funded by the European Union.