Conclusions
Silent subclinical rejection is frequent and a significant contributor to worse long term outcomes for kidney transplant recipients. Until now subAR could only be ruled in or out by invasive and risky per protocol surveillance biopsies, resulting in a significant number of unnecessary biopsies and therefore unnecessary risk to patients compromising safety. Thus, non-invasive tests are clearly needed to identify patients with stable renal function who are harboring subAR in their grafts. In response to this statement of need, we first set out to develop a ”rule in” test to replace the routine use of protocol biopsies as the context of use. However, based on the evidentiary performance data of our biomarker, we determined that it is best used as a “rule out” test and then revised the
proposed COU as the reduction of a large proportion of protocol biopsies in programs that currently utilize these; in those that do not, subjecting far fewer patients to the risks of biopsies together with a reduction in the number of unnecessary (negative) biopsies may provide an attractive monitoring strategy (24). To these ends, TruGraf is the first and only non-invasive test designed and validated for use in ruling out silent subclinical rejection in kidney transplant recipients with stable renal function.
Non-invasive blood testing can be done more frequently than surveillance kidney biopsies, is significantly less invasive, less painful and risky for patients, and may result in a considerable cost savings to the health delivery system.
Conflict of Interest
MRF, SBK and SR are full-time employees of Eurofins-Transplant Genomics, who developed the TruGraf test described in this manuscript. JJF and MMA are consultants to Eurofins-Transplant Genomics,