Application of trugraf® v1: A novel molecular biomarker for managing kidney transplant recipients with stable renal function
Am J Transplant
TruGraf® v1 is a DNA microarray-based blood test to assess immune status in kidney transplant recipients, which has been previously validated in patients identified as Transplant eXcellence (TX: stable serum creatinine, normal biopsy, indicative of immune quiescence), and not-TX (renal dysfunction and/or rejection on biopsy). TruGraf v1 is intended for use in subjects with stable renal function to measure immune status as an alternative to surveillance biopsies. In this study, simultaneous blood tests and clinical assessments were performed in 192 patients from 7 transplant centers as an early access program to evaluate TruGraf v1 and its impact on clinical decision making. The molecular testing laboratory was blinded to renal function and biopsy results. Overall TruGraf v1 accuracy (concordance between TruGraf v1 result and clinical and/or histologic assessment) was 74% (142/192) and a result of TX was accurate in 116/125 (93%). The negative predictive value was 90%, sensitivity 74%, and specificity 73%. TruGraf v1 has the potential to support a clinical decision to avoid unnecessary surveillance biopsies with high confidence, making it an invaluable addition to the transplant physician's toolkit for managing patient health by avoiding painful and risky invasive biopsies, reducing healthcare costs, and enabling frequent assessment of patients with stable renal function to confirm immune quiescence.