VP: Serum creatinine testing, along with other markers developed many years ago as tools to surveil the well-being of kidney allografts have proven themselves to be poor markers of graft health. We know that injury that happens within the graft happens much, much earlier than the elevation of the serum creatinine. We know that these early changes that occur within the graft are not picked up by serum creatinine yet they lead to irreversible damage within the graft, something that will thereafter lead to graft loss and return of the patients to dialysis.
In brief, I think that serum creatinine, along with other markers, including donor specific antibodies, have been vastly outperformed by the development of novel markers like donor-derived cell-free DNA, which can much earlier detect injury of the graft inclusive of rejection. AlloSure® was commercially released in 2017 following its approval by the Center for Medicare and Medicaid Services (“CMS”). Around the same time, a study was published in the Journal of the American Society of Nephrology demonstrating the clinical validation of the assay to evaluate patients for underlining rejection. After we started using AlloSure in our clinical practice, we came to see very quickly that this assay outperforms other commercial tests and tools that we had available to evaluate the grafts for injury inclusive of rejection.
As we acquired more experience with it, we started using it more broadly. And now, not only us, but more than 160 transplant centers the United States have adopted AlloSure as an assay of choice to evaluate the kidney allograft recipients for ongoing rejection.