The detection of biomarkers in body fluids is of great importance for disease early diagnosis. The clinical practice uses typically immunoassay methods (e.g. ELISA, Enzyme-Linked Immuno Sorbent Assay, and related techniques) for biomarker determination. Unfortunately, these techniques fail dramatically in a wide variety of cases where the concentration of biomarkers falls below the limit of detection (LOD). The Alzheimer’s disease (AD) is one real example. Nowadays the AD diagnosis from blood collection is not possible just for the above-mentioned reason. The AD biomarkers are low abundant in blood and they can be determined only in cerebrospinal fluid (CSF), thus requiring a highly invasive intervention on the patient (lumbar puncture) under hospitalization, causing also high costs for the public health. SensApp seeks to develop a bench-top “super-sensor” able to determine low abundant AD biomarkers simply in plasma, from peripheral blood, for very early and non-invasive 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 LOD. 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. 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.

Cancer biomarkers circulating in body fluids have been shown to reflect the pathological process and for this reason can be used for cancer diagnosis, prognosis and choice for therapeutic interventions. It is proven that their detection is a key to new minimal-invasive detection approaches. However, barriers to wide spread use of similar approaches are lack of test sensitivity, specificity and limited availability of low cost detection platforms. This project is focused at developing a compact plasmonic-based device with integrated microfluidic circuit and functionalized nanostructures for the detection of DNA, microRNA and tumor autoantibodies cancer biomarkers. The aim is to detect cancer biomarkers circulating in blood with improvement in sensitivity of factor up to 1000, reduction in cost of platform of factor ranging from 2 to 4 compared to today’s available techniques and analysis time less than 60 minutes. The proposed detection approache will provide ultrasensitive detection of biomolecular systems with no need for complex sample chemical modifications thus allowing direct and simple assays to be performed. Within the project a bimodal industrial prototype will be developed integrating novel surface plasmon resonance imaging and plasmon-enhanced fluorescence sensing technologies, respectively. Automated fabrication processes suitable for low cost mass production will be developed and applied to produce disposable integrated chips. Prototype will be specifically fabricated for early diagnosis and prognosis of colorectal cancer. The team includes partners holding cross-disciplinary competencies needed to achieve the proposed results, including two of the first five plasmon resonance groups in the world, the inventor of surface plasmon microscopy – also known as surface plasmon resonance imaging- and plasmon-enhanced fluorescence spectroscopy, and full European value chain including disposable chip and readout platforms design, development and manufacturing.