Fostering Advanced Sepsis diagnostics Technology - etapp 2

Purpose and goal

Sepsis is the leading cause of death in hospitals, affecting 3.4 million people in the EU and 1.7 million in the US each year. Although sepsis can rapidly progress from symptoms to death within a day, current diagnostic methods take several days to identify the pathogen and its antibiotic susceptibility. The aim of this project is to develop a macro-to-micro solution (FAST) that isolates bacteria from blood within 30 minutes for rapid diagnostics.

Expected effects and result

Through the deeptech project, we will develop the first prototype of our FAST solution and conduct tests in a laboratory environment to ensure its functionality and performance. The goal is to collect the necessary data and create an evidence base that supports the solution´s compliance with the IVDR (In Vitro Diagnostic Regulation). This is an important step towards ensuring that the solution is ready for further development and future use in healthcare.

Planned approach and implementation

The project is implemented in five steps: Optimize and standardize the protocol for reproducible clinical use (M1–M6); conduct independent verification for regulatory submission (M4–M7); test and benchmark in clinical microbiology labs (M3–M10); develop a market-ready kit (M5–M10); and initiate business development and pilot sales to validate the market (M3–M10).