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miRNA-DisEASY Report Summary

Project ID: 690866
Funded under: H2020-EU.1.3.3.

Periodic Reporting for period 1 - miRNA-DisEASY (microRNA biomarkers in an innovative biophotonic sensor kit for high-specific diagnosis)

Reporting period: 2015-12-01 to 2017-11-30

Summary of the context and overall objectives of the project

The miRNA-DisEASY network aims to tackle the emerging needs in clinical diagnostics for the early and selective diagnosis of lung cancer, which is a malignant neoplasm representing the leading worldwide cause of cancer-related death.
This high mortality is due to the poor prognosis of the disease, caused by late disease presentation, tumour heterogeneities within histological subtypes, and the relatively limited understanding of tumour biology. Most lung cancer patients are diagnosed at an advanced stage of disease, and, although a small subset of these patients can be treated with new drugs offering improved survival and reasonable quality of life, the majority of patients can only be treated with palliative chemotherapy. Overall survival remains poor, and many patients die within a few months of diagnosis.
Biomarkers able to stratify for the subtype of lung cancer, prognosticate the course of disease, or predict the response to treatment are in increasing demand. Lung cancer subtyping has traditionally relied on the histopathological observation of resected specimens, bronchoscopic biopsies, fine needle aspirations or sputum, which represent samples with decreasing invasiveness for the patient, but also of increasing challenge for the pathologist, as proportionally fewer tumour cells are captured.
In the last decade, miRNAs measured in resected tumour samples have emerged as biomarkers for tumor diagnosis, prognosis and prediction of response to treatment, thanks to their extreme specificity. Moreover, miRNAs present in sputum, in plasma, in serum or in whole blood have increasingly been explored in the last five years as less invasive biomarkers for the early detection of cancers.
Given the great relevance of a precocious and a more specific diagnosis of lung cancer, the miRNA-DisEASY programme seeks to address this major world health issue advancing three main project objectives:
1. identification of miRNA biomarkers involved in lung cancer pathogenesis;
2. development of a new and low cost sensor kit to reliably detect the identified miRNA biomarkers;
3. Initial small scale clinical sample testing, that could lead to a significant investment in a healthcare product capable of delivering a high specificity, low invasive test for lung cancer, based on a microRNA biomarker panel.

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 the first two years of the miRNA-DisEASY project, activities were mainly related to WP1 “miRNA Biomarkers Discovery” and WP2 “Detection kit Optimization”.
In the framework of WP1, partners worked together on the objective “identification of miRNA biomarkers involved in lung cancer pathogenesis”. The following tasks were completed:
- The miRNA profiling protocols and laboratory practices were compared and standardized between partners
- The microarray analysis using serum samples of Non-Small Cell Lung Carcinoma patients resulted in 53 miRNAs differentially expressed, in which 15 were upregulated and 38 were downregulated.
- The miR score based on miR205 and miR21 could differentiate some subtypes of lung cancer (ADC from SQCC), also in cytological samples.
- The miR score built on miR375 could distinguish some subtypes of lung cancer (low grade NEs from ADCs and SQCCs), but it could not differentiate High Grade Neuroendocrine tumours (LCNEC and SCLCs) from Low Grade NEs, ADCs and SQCC.
- The role of miR-20a-5p was evidenced in the post-transcriptional regulation of CCL1

In the framework of WP2, activities have been focused on the objective “development of a new and low-cost sensor kit to reliably detect the identified miRNA biomarkers”. The partners worked together on the detection kit, implementing two different optical techniques and testing different dyes. The following tasks were completed:
- Optimization of the biochemical assay
- Optimization of the electro-optical architecture of the biosensing device
- Comparison with commercial instrumentation platforms
- Detection limits less than femtomole level (in line with the ranges of some identified circulating in lung cancer patients).
As a result of this collaborative work, partners are evaluating the commercial exploitation of one of the optical detection kits, to be better defined in the two remaining years of the project.

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)

Progress beyond the state of the art relate to the results from the two scientific work packages: the definition of new miR scores to differentiate subtypes of lung cancer, and the reach of a kit detection limit below femtomoles (in line with the miR-21 levels in lung cancer patients). Further progress in both cases are still ongoing and are expected to expand the base of miR scores, and to further improve the limit of detection of the kit.
Impact of this project is relevant firstly for public health, as micro-RNAs are key gene expression regulators, with great potential as biomarkers for cancer staging, diagnosis, prognosis, and therapeutics. The development of a platform suitable to perform rapid tests at hospitals, emergency centers, GP’s offices and pharmacies is going to help to unlock the full potential of miRNAs as circulating biomarkers for lung cancer, helping to bring to reality the concept of a non- invasive “liquid biopsy”.
During the first two years, the impact of the miRNA-DisEASY project has also achieved significant benefits for the seconded personnel, who have experienced the highly international, interdisciplinary and intersectoral character of the project. Interactions between participants from different fields (molecular biology, biotechnology, biochemistry, chemistry, physics, pharmaceuticals, electronic engineering and micro and nanotechnology) have not only enabled secondees to be placed in challenging but very stimulating scientific environments, but also to collaborate in the development of a molecular diagnostic assay platform of global potential.

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