Diagnostic method for early detection of ovarian cancer (part 2)

Purpose and goal

The project aims at the development and demonstration of an innovative sensor system prototype for the early diagnosis of ovarian cancer through a simple blood test. In step 2, we aim to make our instrument (e-nose) faster, operator-friendly, and automated and our analysis method more robust using a three-fold approach: core technical development to TRL6 (demonstration in relevant environment), clinical pilot study with several hundreds of samples and continued consideration of patient aspects, and completion of the regulatory documentation for CE and FDA approval.

Expected effects and result

Multidisciplinary and cross-border collaboration between highly specialized healthcare, academic and business actors, and active involvement of patients, healthcare providers, other relevant end-users, and the society will be crucial for the creation of value, quality, and benefit of the intended solution. At the end of the project, we expect a clear step forward in the commercialization process for obtaining CE IVDR and FDA approval, crucial for the market launch, and practical use of the developed product, methodology, and processes.

Planned approach and implementation

The project is structured in four work packages (WPs): WP1 Core technical development: Model development, measurements, analysis, calibration procedures WP2 Development of the system prototype: Technical upgrades, automation, user interface WP3 Prospective study: Data management, documentation, reporting WP4 Patient aspects: Cooperation with patient representatives Project coordination and management, communication, dissemination and exploitation strategies, and management of IP complete the planned structure and implementation of the project.