The U.S. Food and Drug Administration (FDA) has approved iBox, a French-developed algorithm designed to predict kidney graft survival for up to 10 years following transplantation. Developed over 15 years by Professor Alexandre Loupy and his team, iBox analyzes over 85 pre- and post-transplantation parameters to provide clinicians with insights into the long-term viability of kidney grafts, potentially transforming post-transplant care.
The iBox algorithm, first created in 2019, has been validated in 12 European and American centers, as well as in three randomized clinical trials. The algorithm's development was supported by the American Society of Transplantation (AST) and the Transplant Therapeutics Consortium (TTC), with contributions from pharmaceutical companies including Novartis, Sanofi, and Bristol Myers Squibb. The European Medicines Agency (EMA) qualified iBox in December 2022.
iBox offers clinicians a detailed view of potential functional decline trajectories, enabling precise adjustments to treatment regimens. By identifying the effects of therapeutic changes on long-term graft survival, iBox allows for more informed decision-making. The algorithm's implementation can also lead to substantial benefits for healthcare systems by optimizing the use of medical resources and avoiding ineffective treatments, ultimately reducing costs while enhancing the quality of care.
According to Professor Jon Kobashigawa, president of the American Society of Transplantation, "The FDA qualification of iBox brings us closer to cutting-edge clinical tools capable of extending the lives of transplant patients. This innovation marks a turning point in the modernization of clinical trials and medical follow-up."
The developers of iBox believe its algorithmic model could be adapted to other medical specialties, potentially revolutionizing predictive medicine and clinical trials beyond kidney transplantation.
