Abstract
Sub-optimal sensitivity and specificity in current allograft monitoring methodologies underscore the need for more accurate and reflexive immunosurveillance to uncover the flux in alloimmunity between allograft health and the onset and progression of rejection. QSant—a urine based multi-analyte diagnostic test—was developed to profile renal transplant health and prognosticate injury, risk of evolution, and resolution of acute rejection. Q-Score—the composite score, across measurements of DNA, protein and metabolic biomarkers in the QSant assay—enables this risk prognostication. The domain of immune quiescence—below a Q-Score threshold of 32—is well established, based on published AUC of 98% for QSant. However, the trajectory of rejection is variable, given that causality is multi-factorial. Injury and subtypes of rejection are captured by the progression of Q-Score. This publication explores the clinical utility of QSant across the alloimmunity gradient of 32–100 for the early diagnosis of allograft injury and rejection.
Highlights
It is not surprising that advances in immunosuppression treatment for kidney transplant recipients have not had a more dramatic impact on the improvement of long-term allograft survival [1]
This study demonstrates the clinical utility of serial monitoring via QSant in prospeca real-world data paradigm
The real-world data (RWD) cohort (n = 235) of both adult and pediatric renal transplant patients demonstrated a spectrum across the Q-Score distribution (Figure 2)
Summary
It is not surprising that advances in immunosuppression treatment for kidney transplant recipients have not had a more dramatic impact on the improvement of long-term allograft survival [1]. Recent studies [3,4] have underscored the temporal lag between the onset of intra-graft molecular signals of rejection [5]—where the allograft has patchy histological injury, frequently missed by a needle biopsy (Figure 1) with putative function [6]—and severe dysfunction. There is a critical unmet need to uncover this early stage-shift of acute rejection when injury is mild and potentially reversible. This requires the diagnostic to independently detect rejection, without the testing trigger being a change in graft function [7,8]; be able to risk stratify the severity of rejection without the inherent reader bias observed for the allograft biopsy [9]. The clinical validity of a diagnostic with this specification will provide an improved standard for allograft surveillance, enabling real-time immunosuppression titration
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