The Real-life Experience of Developing and Commercializing TruGraf, a
Validated Non-Invasive Transplant Biomarker
Abstract
Despite improvement in short-term outcomes, long-term results for kidney
transplant recipients remain suboptimal. Immunological rejection is a
leading cause of graft failure and recent research points to undetected
“silent” subclinical acute rejection as a key component of this
problem. While biopsies remain the gold-standard method for detecting
silent rejection, non-invasive methods offer significant advantages
especially in terms of patient safety and for serial monitoring of
stable patients. This manuscript details the real-life challenges
involved in the ultimately successful development and commercialization
of TruGraf, a clinically validated, blood-based gene expression assay
that offers the potential to reduce the use of surveillance (protocol)
biopsies in renal transplant recipients with stable renal function.