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Super-sensitive detection of Alzheimer’s disease biomarkers in plasma by an innovative droplet split-and-stack approach

Periodic Reporting for period 1 - SensApp (Super-sensitive detection of Alzheimer’s disease biomarkers in plasma by an innovative droplet split-and-stack approach)

Reporting period: 2019-01-01 to 2019-12-31

The Alzheimer’s disease (AD) is a progressive and irreversible neurodegenerative disorder, which leads to death. It represents the major cause of dementia in the elderly population, with a great socio-economic impact in the worldwide community. Estimates vary, but experts evaluated that nowadays around 30 millions of people are affected by AD and, taking into account the increase of life expectation, this community is likely to rise to about 150 million people by 2050. The current guidelines for clinical diagnosis of AD establish the determination of specific protein biomarkers (Amyloid-beta, tau, P-tau) in cerebrospinal fluid (CSF) through ELISA kit and positron emission tomography (PET) of the brain with amyloid tracer. However, PET is highly expensive and not always available in clinics and lumbar puncture for CSF collection is an extreme invasive intervention that requires hospitalization and hinders follow-up programs during therapies. Nowadays the traditional ELISA kits cannot determine such biomarkers in peripheral blood due to their abundance well below the standard sensitivity that is of 50-100 pg/mL. Therefore, by the time it is recognized, the disease has been progressing for many years. In this framework an early diagnosis of AD is crucial for saving lives.

SensApp seeks to develop a prototype of what we call “super-sensor” for determining low abundant AD biomarkers in human plasma for rapid and non-invasive AD diagnosis in routine clinical practice. We will develop an outstanding innovative technology that we call droplet split-and-stack (DSS), able to stack the biomarker molecules in sub-microlitre volumes on a solid support before the immunoreactions, thus avoiding diffusion limits and improving significantly the current limits of detection well below 1 pg/mL. The super-sensor will be fully automated and cost-effective. An integrated micro-system in polar materials will split the mother drop of the plasma sample in tiny droplets through electric fields and will accumulate them on a microscale site, while an innovative integrated optical system will detect the fluorescence signal directly on the reaction support. This super-sensor will enable in future a faster and non-invasive diagnosis of AD simply through a routine blood test, thus opening the route to highly efficient screening programs among the population. SensApp will lay the foundations for a future European industrial leadership involved in all of those clinical studies where the detection of low abundant biomarkers is of vital importance for the welfare of society.
The work performed in the first year of the project is in line with the Grant Agreement and is summarized in the following:

- Creation of the logo, the webpage with .eu domain and the social accounts of the project on Twitter, Facebook, Instagram and YouTube, for immediate visibility
- First brochure with the objectives of the project at the beginning of the project
- Flyer with first results at the end of first year project
- Document with a plan for managing the data produced by the project
- Inclusion of publications produced by the project in Zenodo repository:
- Plan with clear strategies for promoting the project and for exploiting the deliverables
- We presented the project in more than 5 international scientific events
- We published 1 master’s thesis and more than 10 articles on non-scientific journals for dissemination purposes
- First promotional movie of the project
- Document containing the first specifications of the super-sensor, with a target sensitivity in human plasma below 1 pg/mL
- We established the functional characteristics and the design of the super-sensor
The prototype of super-sensor will allow us to overcome the current limits of detection of standard ELISA kits by reaching values well below 1 pg/mL. Therefore the super-sensor will be able to perform a faster and non-invasive diagnosis of the Alzheimer’s disease by a simple blood test. After the end of the project, the super-sensor will allow clinicians to perform highly efficient screening programs among the population and to experiment with follow-up therapies.
Logo of the project SensApp