Reference: CPP2022-009817
Duration: 01/10/2023 – 30/09/2026
Early and accurate detection of endometrial cancer (EC) is an important factor in EC survival. EC is the 6th most common cancer and the 4th leading cause of cancer deaths in women. By 2040 the number of new EC cases diagnosed worldwide is expected to increase by 46% increase, mainly due to an increase in agepopulation and obesity. Currently, EC diagnostic process is initiated in women who present with abnormal vaginal bleeding (~50 million women/year worldwide) of which only 5-10% will ultimately be diagnosed with EC. EC mostly affects postmenopausal women, but 14% of cases are diagnosed in premenopausal women. The current diagnostic process includes minimally invasive (pipelle biopsy) or invasive endometrial biopsies (hysteroscopy) to reach a final diagnosis. Today, there is no strategy for early detection, screening, or prevention. This is the context of the ScreenEC project, which aims to develop and validate CYTOMARK, a non-invasive IVD for EC detection as a screening tool targeting high-risk populations. CYTOMARK is based on protein biomarkers analyzed in cervical fluids and therefore, is a non-invasive method. The specifics objectives of ScreenEC are: (i) establish a repository of cervical fluid samples and associated data from patients starting the EC diagnostic process; (ii) develop proprietary antibodies to the biomarkers selected prior to project start; (iii) develop the CYTOMARK IVD prototype, based on an immunoassay with proprietary antibodies; (iv) analytically and clinically validate the CYTOMARK IVD prototype; (v) develop a proof-of-concept POCT version of CYTOMARK utilizing electrochemical immunosensors; and (vi) validate the performance of both the IVD and the POCT device in detecting EC in asymptomatic and high-risk populations.
To this end, the ScreenEC project will be executed by a multidisciplinary consortium formed by four partners: one private company (MiMARK), and three public institutions (VHIR, IDIBELL, and ICN2), all with expertise in different disciplines that will work together to develop the first screening test for EC. The consortium is designed so that partners complement each other to ensure that all the infrastructure for the effective execution of the project is provided. MiMARK, a spin-off from VHIR based in Barcelona Scientific Park, is a women-led spin-off dedicated to womens health that aims to reshape gynecological diagnostics, based on a new liquid biopsy matrix, and gynecologic fluids. MiMARK has experience in immunoassay (ELISA) technology development, sample pre-analytics, entrepreneurship and healthcare innovation, business development, market access and reimbursement, and regulatory & quality. MiMARK has the technical knowledge and physical capabilities to perform the objectives planned for this project. VHIR and IDIBELL promote translational biomedical research in their respective hospitals, have been collaborating for years in the field of EC diagnosis and prognosis and their key role in ScreenEC is the recruitment of samples. To complete the team, ICN2 will offer their expertise in the development of high-performance cutting-edge biosensors for healthcare and environmental applications to transfer MiMARKs IVD technology into an electrochemical POCT system. This project is not only a disruption in the current methods of EC diagnosis but also involves an impact on patients through early detection, non-invasive, and highly specific detection of EC, consequently improving their quality of life and survival expectancy.