The iBox validation study from the Paris Transplant Group has been published in the British Medical Journal. The news was announced today by CareDx, Inc.
CareDx launched KidneyCare at the American Transplant Congress in June 2019. KidneyCare includes the iBox technology as a prognostic measurement alongside multimodality testing with AlloSure® and AlloMap®. CareDx holds the exclusive rights to commercialize the iBox algorithm in the US, through its partnership with Cibiltech, a Paris-based medical technology company.
“Our BMJ publication shows the algorithm we created can provide standardization across centers worldwide,” said Alexandre Loupy, MD, Director of the Paris Transplant Group. “The iBox risk prediction score may help guide patient monitoring and further improve the design and the development of a valid and early surrogate endpoint for clinical trials.”
The BMJ study’s aim was to validate the iBox integrative system to predict long-term allograft failure. The study assessed the performance of the iBox risk prediction score in 7,557 kidney transplant recipients with a median follow-up time of 7 years, across 10 academic medical centers from the United States and Europe. The iBox risk prediction score combines allograft function, histological and immunological parameters with HLA donor specific antibody profiling, to accurately predict the risk of long-term kidney allograft failure as well as to identify significant changes at the time of therapeutic interventions.
“Transplantation provides an incredibly rich data set and is ripe for using augmented intelligence tools to better assess risk and help physicians better manage their daily patient care. Our next step is clinical utility, which we capture through our OKRA registry measuring outcomes from patients surveilled with KidneyCare,” said Sham Dholakia, MD, DPhil, CareDx’s Senior Vice President of Medical Affairs & Clinical Operations.