Periodic Reporting for period 1 - WomEC (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)
Periodo di rendicontazione: 2023-10-01 al 2024-09-30
The WomEC project addresses a pressing global health issue: bon-accurate and often invasive diagnosis of endometrial cancer (EC), the most common gynecological cancer in high-income countries. Despite affecting close to 450,000 women every year, the diagnostic tools available for EC remain invasive, slow, and inefficient. Approximately 31% of women who present with symptoms and undergo endometrial biopsy fail to receive a final diagnosis due to insufficient cellular material. As a result, these patients are subjected to invasive follow-up procedures such as hysteroscopy, leading to delays in treatment, increased healthcare costs, and negative impacts on patient quality of life. The project’s primary objective is to develop and clinically validate WomEC, an innovative in vitro diagnostic (IVD) tool to improve the accuracy and management of EC diagnosis. WomEC will detect EC through the analysis of protein biomarkers in uterine fluid, eliminating the reliance on cellular material from endometrial biopsies. This minimally invasive diagnostic tool is expected to provide highly accurate results, with a sensitivity of 99% and a negative predictive value of 97%, significantly reducing the need for invasive procedures.By leveraging WomEC’s novel biomarker technology, the project aims to align with global healthcare trends such as precision medicine, value-based care, and personalized healthcare. The results of the project will not only improve clinical outcomes for women but also reduce healthcare costs by minimizing unnecessary diagnostic steps and invasive procedures.The project’s motivation is deeply rooted in the political and strategic context of improving women’s health, a field that has long suffered from underrepresentation and insufficient innovation. The WomEC project contributes to the European Commission’s goals of achieving gender equity in healthcare and improving diagnostic tools for women’s cancers. It also aligns with broader global efforts to reduce cancer-related mortality by providing earlier, more accurate detection and less invasive diagnostic options.
During the first year of the WomEC project, several key technical and scientific milestones were achieved, advancing the development of the diagnostic tool.
1. Patent Strategy: we have increased the IP protection of our biomarkers and key reagents and performed competitive intelligence
2. Regulatory and Quality: Implementation and maintenance of the QMS and conducting internal audits to prepare MiMARK for ISO 13485 certification were made. We performed a comprehensive regulatory pathway analysis for both EU and US and key contacts with regulatory entities to gather feedback have been made.
3. Market analysis, market access, and health-economics: we conducted primary and qualitative research and made progress in generating a cost-effectivity analysis and a budget impact model for WomEC
4. Immunoassay development: The WomEC assay, based on protein biomarkers from uterine fluid, was successfully developed.
5. Industrialization and Production: The project progressed in scaling up production, with key raw materials characterized. Strategic partnerships with subcontractors were established to ensure smooth transitions from development to large-scale manufacturing.
6. Patient Recruitment and Biobank Expansion: A biobank of over 1,000 samples, including 240 EC cases, was successfully created. These samples are essential for the ongoing pre-clinical validation studies that will further confirm WomEC’s diagnostic accuracy.
7. Algorithm Fine-tuning and Verification: a first testing cohort of 120 samples has been processed. Further work is needed to have algorithm freeze.
8. WomEC Px: we have progressed in the development and validation of biomarkers related to prognostic factors of EC to generate an advanced version of WomEC, including prognostic biomarkers.
1. Patent Strategy: we have increased the IP protection of our biomarkers and key reagents and performed competitive intelligence
2. Regulatory and Quality: Implementation and maintenance of the QMS and conducting internal audits to prepare MiMARK for ISO 13485 certification were made. We performed a comprehensive regulatory pathway analysis for both EU and US and key contacts with regulatory entities to gather feedback have been made.
3. Market analysis, market access, and health-economics: we conducted primary and qualitative research and made progress in generating a cost-effectivity analysis and a budget impact model for WomEC
4. Immunoassay development: The WomEC assay, based on protein biomarkers from uterine fluid, was successfully developed.
5. Industrialization and Production: The project progressed in scaling up production, with key raw materials characterized. Strategic partnerships with subcontractors were established to ensure smooth transitions from development to large-scale manufacturing.
6. Patient Recruitment and Biobank Expansion: A biobank of over 1,000 samples, including 240 EC cases, was successfully created. These samples are essential for the ongoing pre-clinical validation studies that will further confirm WomEC’s diagnostic accuracy.
7. Algorithm Fine-tuning and Verification: a first testing cohort of 120 samples has been processed. Further work is needed to have algorithm freeze.
8. WomEC Px: we have progressed in the development and validation of biomarkers related to prognostic factors of EC to generate an advanced version of WomEC, including prognostic biomarkers.
WomEC represents a significant advancement in the field of gynecological diagnostics, introducing a minimally invasive, biomarker-based approach that moves beyond traditional pathological examinations. This innovation shifts the diagnostic focus from the subjective interpretation of biopsy samples to a accurate, protein-based assessment that provides objective and reproducible results.
The project also advances the concept of a liquid biopsy using gynecological fluids, which is a novel matrix in this field. By analyzing the soluble fraction of uterine fluid, WomEC avoids the limitations associated with inadequate cellular material in endometrial biopsies. This method has the potential to revolutionize EC diagnostics, offering faster, more reliable results with less discomfort for patients.
Key impacts of the WomEC project include:
• Enhanced Diagnostic Accuracy: With 99% sensitivity and 97% negative predictive value, WomEC offers a diagnostic accuracy that surpasses current methods, ensuring earlier and more reliable detection of EC.
• Reduced Invasiveness: By eliminating the need for invasive follow-up procedures like hysteroscopy, WomEC significantly improves patient comfort and reduces healthcare-associated risks.
• Rule out for negative patients: WomEC will provide a more efficient patient management and will facilitate providing negative diagnosis to patients, thus decreasing patient anxiety.
To ensure the tool’s commercial success, ongoing efforts are focused on obtaining regulatory approvals, scaling production, and establishing reimbursement strategies for both the EU and US markets.
The project also advances the concept of a liquid biopsy using gynecological fluids, which is a novel matrix in this field. By analyzing the soluble fraction of uterine fluid, WomEC avoids the limitations associated with inadequate cellular material in endometrial biopsies. This method has the potential to revolutionize EC diagnostics, offering faster, more reliable results with less discomfort for patients.
Key impacts of the WomEC project include:
• Enhanced Diagnostic Accuracy: With 99% sensitivity and 97% negative predictive value, WomEC offers a diagnostic accuracy that surpasses current methods, ensuring earlier and more reliable detection of EC.
• Reduced Invasiveness: By eliminating the need for invasive follow-up procedures like hysteroscopy, WomEC significantly improves patient comfort and reduces healthcare-associated risks.
• Rule out for negative patients: WomEC will provide a more efficient patient management and will facilitate providing negative diagnosis to patients, thus decreasing patient anxiety.
To ensure the tool’s commercial success, ongoing efforts are focused on obtaining regulatory approvals, scaling production, and establishing reimbursement strategies for both the EU and US markets.