This week, we initiated the first clinical study of the BioMAdvanced Diagnostics kidney rejection test.
Our dedicated team is working diligently to ensure that the test results will be available by October 2023, aligning with our deadline for CE marking application in 2025.
In this study, we will utilize the BioMAdvanced Diagnostics kidney rejection test to analyze 450 blood samples obtained from patients who have undergone kidney transplantation and compare the results to biopsy outcomes made at the same time as the blood sampling. Our objective is to accurately determine which samples exhibit stability and which samples indicate risks of “silent” rejection.
How we can achieve such prompt results ?
The Nantes CHU has provided us with a valuable bio-collection of samples from transplanted patients. The final preparatory step was to inform properly the patients. Having completed these necessary preparations, we were able last week to proceed with the study starting with sample screening.
It is important to highlight that our test may eventually enable reducing the need for expensive and invasive biopsies.
« With this study, we are entering a clinical phase which takes us a giant step forward and shows our total control of the processes. The results will be available at fall and I can’t wait to share them.” Frédéric Pette, Co-founder and President of BioMAdvanced Diagnostics
