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,