Development and clinical validation of an electrochemical biosensor for detection of tumor biomarkers via liquid biopsy: from early diagnosis to in situ monitoring

• Grant number: 24/23398-4
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: April 01, 2025
• End date: March 31, 2027
• Field of knowledge: Interdisciplinary Subjects
• Principal Investigator: Daniela Silvestrini Fernandes
• Grantee: Daniela Silvestrini Fernandes
• Pesquisadores principais: Gabriela Cristina Silva Prado
• Associated researchers: Cristiano Ceron Jayme ; Luciana Nogueira de Sousa Andrade ; Miyuki Uno ; Roger Chammas
• Associated research grant: 24/10416-4 - Development and clinical validation of an electrochemical biosensor for detection of tumor biomarkers via liquid biopsy: from early diagnosis to in situ monitoring, AP.PIPE
• Associated scholarship(s): 25/05658-1 - Development and clinical validation of an electrochemical biosensor for the detection of tumor biomarkers via liquid biopsy: from early diagnosis to in situ monitoring, BP.PIPE

Abstract

The present project aims to respond to technological challenges present in the development of an electrochemical device for screening, diagnosis and monitoring of brain tumors (gliomas). It can also be applied to some classes of other types of highly aggressive tumors, which have in common the expression of the human epidermal growth factor receptor a (EGFRvIII), such as tumors of the central nervous system, pancreas and lungs. This device was previously developed with the aim of creating a minimally invasive test for evaluating tumor biomarkers present in patients' plasma, mainly aimed at brain tumors of the glioma and glioblastoma (GBM) types. The main technological challenges that currently exist for the present device are: clinical validation of the device in a relevant environment (hospital - Hospital das Clínicas de São Paulo (HC-SP) and ICESP - Cancer Institute of the State of São Paulo), increasing the size sample; evaluating the detection capacity of the device in relation to disease staging; the separation of exosomes by different routes, their characterization and quantification in order to identify which are the most efficient separation routes and compare their cost and time; evaluation of the selectivity and specificity of the device and the implementation of a pilot with the technological solution on the market. For the purpose of complementation, patient data must be collected and form part of a database to later be associated with analysis tools via artificial intelligence. Currently, the way to detect most brain tumors and other types of tumors mentioned above requires surgery to collect tissue or genetic profiling of tumors to classify the disease and guide therapy. Therefore, it is extremely necessary to implement more attractive and less invasive diagnostic alternatives on the market, in addition to creating tracking and screening mechanisms, which until now have been little developed for brain tumors. The suitability of blood-based molecular profiles for detection and monitoring of molecular processes may be able to provide a means for minimally invasive diagnostics, overcoming limitations in the tissue acquisition process. The identification of specific cancer biomarkers at an early stage can significantly improve the clinical success rate and consequently reduce disease-related mortality. In this way, our developed device can be used in the clinical scenario (in situ), significantly renewing the field of medical oncology and public health, in addition to being highly attractive due to its low cost, speed of operation and minimally invasive method when compared to other methodologies. traditional diagnostic methods. (AU)