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PHOCNOSIS Report Summary

Project ID: 634013
Funded under: H2020-EU.3.1.

Periodic Reporting for period 1 - PHOCNOSIS (Advanced nanophotonic point-of-care analysis device for fast and early diagnosis of cardiovascular diseases)

Reporting period: 2015-09-01 to 2017-02-28

Summary of the context and overall objectives of the project

There is an ever-increasing demand for novel and more efficient point-of-care testing (POCT) devices for the early diagnosis of diseases, with a special interest in cardiovascular diseases (CVD). The most recent statistics from the European Heart Network (EHN) and the European Society of Cardiology (ESC) show that CVD remain as the leading cause of death in the European Union (EU) accounting for 1.9 million deaths each year (40% of all deaths in the EU) with an estimated associated cost of almost €196 billion per year. Despite these numbers, CVD can be successfully treated when detected early and managed according to best practices. Therefore, having efficient detection tools for the implementation of preventive testing and early diagnosis is a key factor for reducing CVD mortality rates.

The PHOCNOSIS project aims at developing an ultra-sensitive, compact and low-cost POCT device based on nanophotonic and micro-/nanofluidic technology for its application to minimally-invasive early diagnosis of CVD. This POCT device will significantly help to reduce the actual costs designated for early diagnosis and to implement mass screening programs, allowing a significant contribution to the improvement of the citizens’ health status and to the sustainability of healthcare systems.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In summary, the main outcomes from the work carried out during Period 1 have been:
- A panel of potential biomarkers for CVD diagnosis has been set, from which the most relevant ones have been selected to work with during the first period of the project.
- The optimal antibodies for the detection of some of those CVD biomarkers have been selected and thoroughly experimentally tested.
- A microfluidic concentration+separation system based on the depletion zone – Isotachophoresis (dz-ITP) principle has been developed using Polydimethylsiloxane (PDMS) material.
- Initial tests for transferring the fabrication process of the microfluidic concentration+separation system to mass production techniques have been successfully carried out.
- The photonic sensing chips based on photonic bandgap (PBG) structures have been designed and initial prototypes have been fabricated and tested.
- An automated laboratory readout platform for the sensing chips has been developed, allowing multiple types of photonic interrogation.
- The transference of the fabrication process of the photonic chips to NIL (nanoimprint lithography) has been started.
- The procedures for the immobilization of the probes onto the photonic sensing structures have been initially developed and validated using planar substrates.
- We have begun working on the transference of the biofunctionalization procedures to the photonic sensing chips for the direct detection of the selected targets.
- The development of the technological sub-systems has been monitored in order to ensure a proper integration between them.
- Several approaches for the proper assembly/integration of the final photonic and microfluidic modules have been evaluated.
- We have defined a preliminary concept for the package of the PHOCNOSIS biochip and its loading into the readout device.
- The optical interrogation system for the “product-like” PHOCNOSIS readout platform has been developed.
- A concept for the electrical excitation of the final on-chip microfluidic concentration+separation system has been defined.
- The collection of clinical samples for the validation of the PHOCNOSIS analysis device has been set up.
- An end-users advisory panel to contribute to the development and validation of the PHOCNOSIS device has been set up.
- Exploitation issues of the project have been addressed by determining the main standards and regulations applying to the PHOCNOSIS analysis device and by elaborating a first draft of the initial exploitation plan.
- Dissemination/communication activities targeting the promotion of the PHOCNOSIS project have been carried out.
- A Data Management Plan (DMP) describing the strategy and procedures for open access publication of results and project data has been elaborated.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The use of the microfluidic and photonic technologies proposed in the PHOCNOSIS project will allow reaching sensitivity levels not obtained before using low footprint nanophotonic sensing technology. This sensitivity level will allow us using the developed technology for the detection of the extremely low concentration levels of cardiac biomarkers present on human samples. Additionally, the analysis concept proposed in PHOCNOSIS will allow having a final device being fast, compact and low-cost, what will open the door to its practical use by the healthcare systems around Europe. The performance of the PHOCNOSIS device will allow analysing several relevant CVD biomarkers in only a few minutes, thus providing very relevant information in order to immediately apply the proper treatment to patients potentially having a cardiac problem.

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