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Reshaping women's health through the understanding of gynecological fluids. WomEC: Antibody-based IVD test based on 5 novel protein biomarkers quantified in liquid biopsy

Project description

Transforming endometrial cancer diagnosis

The EIC-funded WomEC project will revolutionise endometrial cancer diagnosis by detecting a panel of protein biomarkers in the uterine fluid from a minimally invasive pipelle biopsy. WomEC will be implemented in automated immunoassay platforms present in clinical labs. Validated in four studies with 530 patients (99 % sensitivity, 97 % negative predictive value), the solution offers rapid, objective results, reducing diagnostic times and reliance on pathologist expertise. Its high sensitivity minimises false negatives, diminishing invasive procedures and patient anxiety, and ultimately improving quality of life, increasing life expectancy, and reducing healthcare costs. Next steps involve finalising the development of the ELISA technique, clinical validation, and partnering with key IVD players for automation and commercialisation. In addition, an advanced version of WomEC aims to provide prognostic information.

Objective

WomEC is the future of endometrial cancer (EC) diagnosis. It is an in vitro diagnostic test for EC based on 5 novel protein biomarkers that are analyzed in the fluid of a pipelle biopsy, providing a 97% Negative Predictive Value. WomEC has been verified in 4 clinical retrospective studies in 530 patients that resulted in two patents. A verified immunoassay prototype incorporating a proprietary algorithm and antibodies will be completed by January 2023 with clinical validation and commercialization expected for 2024. WomEC is targeted at public and private hospital systems (clinical laboratories) and will benefits woman undergoing the diagnostic process by providing: a faster, more accurate diagnosis, with fewer complications by eliminating the need for invasive tests; and by providing tumor histologic information to improve clinical decision making and optimize surgical treatment leading to a better quality of life, increased life expectancy and reduced cost of care.

Coordinator

MIMARK DIAGNOSTICS SL
Net EU contribution
€ 2 499 999,00
Address
Avenida Dr. Gregorio Marañón, 8, Parc Científic de Barcelona
08035 BARCELONA
Spain

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Este Cataluña Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost
€ 3 853 212,50