The platform HistoPlat implies the development and validation of a mathematical algorithm, potentially combinable with an image analysis software, that, through a multiparametric approach including the immunohistochemical analysis of both expression and localization of multiple markers, allows the histopathologist or oncologist to optimize the diagnosis and prognosis, and to predict the clinical response to therapies directed towards validated and/or innovative molecular targets, also taking into account the individual variability of each patient. The proposed multiparametric platform includes molecular components of the Wnt/β-catenin pathway, and the CD44 as a multifunctional indicator of advanced tumor stages and metastatic disease, as well as parameters related to cell proliferation already in use in diagnostic practice (positive Ki67 and mitotic index). Furthermore, given the recently reported correlation between activation of the pathway in tumor tissue and the immune resistance mechanisms, the platform will also include the expression of immune checkpoint markers.
The proposed biomarkers, even if recognized by the international scientific community as crucial for the development of many tumors, are not yet used in tools diagnostic/prognostic or predictive of the therapeutic response. The multiparametric approach is currently used in diagnostic exclusively for evaluating molecular parameters but not the immunohistochemical ones. COMPETITIVE ADVANTAGES: The multiparametric platform HistoPlat is based on the histological diagnosis and the molecular localization by immunohistochemistry, economically sustainable and hypothetically applicable to the majority of diagnostic and health care sites, both public and private. It also takes into account the individual variability of each patient, and is in line with personalized medicine. Furthermore, a multiparametric approach that allows the simultaneous detection of Wnt pathway-related molecules and immune checkpoint markers could have a predictive value for the clinical response to treatments with the immune checkpoint inhibitors (ICIs) in use in the clinic, and open new perspectives for the development of new combination strategies.