Periodic Reporting for period 1 - LVOCheck (Diagnosis of large vessel occlusion (LVO) in acute stroke for improving access to treatment)
Periodo di rendicontazione: 2023-05-01 al 2024-04-30
The project, ABCDx's development of LVOCheck, is aimed at revolutionizing the diagnosis and triage of stroke patients. It addresses the critical need for rapid identification of large vessel occlusion (LVO) strokes in pre-hospital settings, a major healthcare challenge with significant social and economic impacts. By leveraging a novel diagnostic tool that combines a multi-biomarker approach with advanced data analysis, the project seeks to enable faster and more accurate stroke diagnosis, facilitating timely treatment and potentially improving patient outcomes. The integration of social sciences and humanities is pivotal, particularly in understanding and addressing the socio-economic barriers to stroke care access and the adoption of new technologies across different healthcare systems. The expected impact of the project is substantial, aiming to reduce the time to treatment for stroke patients significantly, thereby decreasing morbidity, mortality, and long-term disability rates, as well as the associated healthcare costs. This initiative aligns with broader political and strategic healthcare goals focused on enhancing patient care, improving clinical outcomes, and optimizing resource utilization in emergency medical services.
Throughout the first part of the project, ABCDx focused on the technical and scientific development of LVOCheck, conducting extensive research and development activities. This included the formulation and validation of the biomarker-based rapid test, preliminary software development for data analysis, and preparation of the pilot clinical study to assess efficacy and accuracy.
The main results in this first year were:
1) The development of the POCT
2) The development of the smartphone reader
3) The development of the APP
4) The development of the analysis component
5) The development of the Cloud/communication platform
6) The development of the QMS
7) Submiting a breakthrough device designation request at FDA
8) Finalise two clinical studies to prepare the final one.
Major achievements encompass successfully demonstrating LVOCheck's potential in reducing diagnosis time for stroke patients, thereby paving the way for quicker treatment decisions. The project's outcomes signify a significant advancement in pre-hospital stroke care, offering a novel solution for early detection of large vessel occlusions.
The main results in this first year were:
1) The development of the POCT
2) The development of the smartphone reader
3) The development of the APP
4) The development of the analysis component
5) The development of the Cloud/communication platform
6) The development of the QMS
7) Submiting a breakthrough device designation request at FDA
8) Finalise two clinical studies to prepare the final one.
Major achievements encompass successfully demonstrating LVOCheck's potential in reducing diagnosis time for stroke patients, thereby paving the way for quicker treatment decisions. The project's outcomes signify a significant advancement in pre-hospital stroke care, offering a novel solution for early detection of large vessel occlusions.
The main results in this first year were:
1) The development of the POCT from duplex to triplex
2) The development of the smartphone reader with higher resolution
3) The development of the APP with better front end
4) The development of the analysis component including more parameters
5) The development of the Cloud/communication platform much more robust
6) The development of the QMS
7) Submiting a breakthrough device designation request at FDA
8) Finalise two clinical studies to prepare the final one.
To ensure the further uptake and success of the ABCDx project outcomes, key needs include further research to refine and validate LVOCheck's efficacy, demonstration projects to showcase its real-world application, and strategies for commercialization and market access. FTO analysis support and navigating regulatory and standardization frameworks are critical for securing market entry. Additionally, securing finance for scale-up (series A), exploring internationalization opportunities, and engaging with stakeholders for supportive policies will be essential. These steps will help realize the project's potential impacts on healthcare systems and stroke patient outcomes.
1) The development of the POCT from duplex to triplex
2) The development of the smartphone reader with higher resolution
3) The development of the APP with better front end
4) The development of the analysis component including more parameters
5) The development of the Cloud/communication platform much more robust
6) The development of the QMS
7) Submiting a breakthrough device designation request at FDA
8) Finalise two clinical studies to prepare the final one.
To ensure the further uptake and success of the ABCDx project outcomes, key needs include further research to refine and validate LVOCheck's efficacy, demonstration projects to showcase its real-world application, and strategies for commercialization and market access. FTO analysis support and navigating regulatory and standardization frameworks are critical for securing market entry. Additionally, securing finance for scale-up (series A), exploring internationalization opportunities, and engaging with stakeholders for supportive policies will be essential. These steps will help realize the project's potential impacts on healthcare systems and stroke patient outcomes.