Periodic Reporting for period 1 - BMEVLP (Biomarkers for clinical assessment of lungs intended for transplantation)
Reporting period: 2014-11-01 to 2015-04-30
EVLP has proven its clinical value to increase the number of lungs available for transplantation. Within the first years, the increase, at a center level, is about 30% more lung transplantations generated through EVLP. The limit with EVLP is that the analysis is partly based on subjective criteria. This is acceptable as long as the technique is only used by the most experienced centers, but with dissemination of the technique, more objective parameters would facilitate the use of EVLP and increase security in term of organ function. This project aimed at identifying objective markers of lung function during EVLP. Although a clinical trial is required to determine the success of the project, initial data support the view that significant biomarkers have been identified within the project.
The project has also thoroughly investigated the user needs and it has identified different technology platforms that could be used to improve the objectivity of the EVLP-process. All in all, the project has generated a strong position for future development of EVLP and therefore to offer more lungs to dying persons.
An investment analysis and business plan has been drafted for the proposed biomarkers.
A feasibility study has been performed to investigate the operability of the proposed biomarkers.
From an extensive list, a handful of biomarkers passed all the required tests to become selected biomarkers for a clinical study. This means that they are believed to improve the selection process of EVLP, while being innovative and possible to bring to the market after clinical evaluation and technical adaptation.
Even at this stage an improved understanding of the lung function during EVLP could improve the selection process of donated lungs which in turn could save lives, both through a select and a de-select process. Moreover the work in the project has generated new knowledge and understanding about the clinicians needs and how to get about to support the clinicians needs in term of lung evaluation during EVLP. By pursuing this project further, XVIVO will continue to grow and to develop new and innovative products to facilitate the clinicians’ decision about whether to transplant a lung or not and thereby help the clinicians to save more lives with lung transplantation.