Significant progress in assay development

Mycartis has published a Whitepaper on “objective assessment of fitness of donor organs during perfusion”.

MyCartis has made significant progress in the development of a fast (<30min) immunoassay to objectively assess the fitness of a donor organ during perfusion as well as predict the post-surgery acceptance and survival. This is the first time that an assay meets the required analytical performance criteria required in this emerging field and is ideally suited for repeat (interval) testing during the organ perfusion process. These assay characteristics are made possible through a combination of DMAT® features as well as unique Evalution® platform concepts. When implemented, the transplant surgeon would get timely insight on the organ fitness and gain confidence in the successful outcome of this life-saving procedure.

MyCartis has engaged with a specialized transplant centre to run its first pre-clinical tests in a clinical environment. As a first model case, donor lung organs undergoing perfusion are objectively assessed for their inflammation status using an ultra-fast and reliable IL-1β assay, a choice based on the findings of Prof. Dr. Andrew Fisher (Newcastle) who demonstrated that this biomarker can be predictive on organ fitness as well as subsequent acceptor survival. Together with its fast turnaround time, Evalution®’s specific cartridge form factor allows for repeat testing of the organ, allowing the transplant surgeon to decide on the right timing for transplantation. The same unique model assay concept can be easily applied to other biomarkers, enabling multiplex organ perfusion panel testing. Such perfusion procedure and companion test has the potential of making available for transplant 30% more organs from the initially rejected ones and could therefore have a serious positive effect on waiting list size and mortality. The market potential of perfusion is growing at a double digit CAGR and expands from lungs into heart, liver and other solid organs.