EYEPOC: Point Of Care Biosensor Devices To Detect Biomarkers As Evaluation End- Points For Therapeutic Clinical Trials In Ocular Surface Inflammation

Dry eye disease (DED) is a major and increasing health-care problem due to its high prevalence and capacity to affect patients’ quality of life, work-related issues, and healthcare resources. Its chronic-severe forms are characterized for the possibility of corneal damage, that may lead to a sight-threatening outcome. It is universally recognized that symptoms and clinical signs do not correlate well in DED. Thus, diagnosis of DED is difficult and the development of new pharmacological therapies is hampered by the lack of objective tests for response outcomes in clinical trials. For this reason, there is a scarcity of effective therapies for the treatment of DED.

We and others have already identified in tears and conjunctival epithelial cells of DED patients some molecules and genes with altered expression, specifically involved in the pathogenesis of DED. Some of them are up or downregulated depending on DED severity, suggesting that their expression could be used as activity and/or therapeutic biomarkers. All these DED specific molecules (proteins, genes and/or miRNA could be incorporated as bioreceptors into point-of care (PoC) devices for effective biomarkers detection. The introduction in the clinical management of DED of these PoC devices will provide essential tools for the assessment of objective treatment benefits. Noticeably, CIN2-CSIC has implemented a first PoC laboratory prototype that allows the label-free detection of biomolecular interactions with extremely sensitivity. Most relevant, they have recently demonstrated its ability to directly detect human hormones at physiological levels (below 0.1 pg/ml) or differenciate RNA isoforms (at 1 pM level) through the biointeraction with their specific antibodies or genetic strands previously immobilized on the nanosensors. On the other hand, the Nanobiotechnology for Diagnostics group (Nb4D-CSIC) has been working on PoC devices for monitoring biomolecular interactions on a variety of applications related to the food safety and the clinical field. Particularly, this group has developed and patented an impedimetric transducer platform based on high density interdigitated electrodes for the non-labelled detection of different
biomarkers at nM levels.

This research project intends, based upon our previous knowledge and in the results obtained here, to develop specific and sensitive PoC devices based on molecule expression (cytokines and/or genes) specifically involved in the development of DED disease, in ocular surface tissues that can be obtained in a minimally invasive way, (tears and conjunctival epithelial cells) and that therefore could be used in clinical trials as evaluation end-point outcomes for DED. This will let us develop new diagnostic tests that will increase the capacity of new therapeutic candidates to show significant results in clinical trial, with the consequence of more drugs into the market and find newtherapeutic drugs for DED disease.

 

Finantial support: Proyecto Intramural CIBER-BBN
Participating Institutions: CIN2-CSIC, NB4D-CSIC, IOBA-UVA, GQNA-CSIC
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