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  • Application of TruGraf v1: ...
    Marsh, C.L.; Kurian, S.M.; Rice, J.C.; Whisenant, T.C.; David, J.; Rose, S.; Schieve, C.; Lee, D.; Case, J.; Barrick, B.; Peddi, V.R.; Mannon, R.B.; Knight, R.; Maluf, D.; Mandelbrot, D.; Patel, A.; Friedewald, J.J.; Abecassis, M.M.; First, M.R.

    Transplantation proceedings, April 2019, 2019-Apr, 2019-04-00, Letnik: 51, Številka: 3
    Journal Article

    TruGraf v1 is a laboratory-developed DNA microarray-based gene expression blood test to enable proactive noninvasive serial assessment of kidney transplant recipients with stable renal function. It has been previously validated in patients identified as Transplant eXcellence (TX: stable serum creatinine, normal biopsy results, indicative of immune quiescence), and not-TX (renal dysfunction and/or rejection on biopsy results). TruGraf v1 is intended for use in subjects with stable renal function to measure the immune status as an alternative to invasive, expensive, and risky surveillance biopsies. In this study, simultaneous blood tests and clinical assessments were performed in 192 patients from 7 transplant centers to evaluate TruGraf v1. 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 of 125 (93%). The negative predictive value for TruGraf v1 was 90%, with a sensitivity 74% and specificity of 73%. Results did not significantly differ in patients with a biopsy-confirmed diagnosis vs those without a biopsy. TruGraf v1 can potentially support a clinical decision enabling unnecessary surveillance biopsies with high confidence, making it an invaluable addition to the transplant physician's tool kit for managing patients. TruGraf v1 testing can potentially avoid painful and risky invasive biopsies, reduce health care costs, and enable frequent assessment of patients with stable renal function to confirm the presence of immune quiescence in the peripheral blood. •There is an urgent need for non-invasive testing of kidney transplant recipients with stable renal function to confirm adequacy of immunosuppression as a key element to preventing future rejection and especially Antibody Mediated Rejection.•Current monitoring techniques to detect kidney injury includes measuring serum creatinine levels and immunosuppressive drug levels, both of which are insensitive and non-specific and routine surveillance (protocol) biopsies are both expensive and invasive, have significant intra-observer variation in interpretation of biopsy results and are unsuitable for frequent monitoring.•TruGraf® v1 is a is a laboratory developed DNA microarray-based gene expression blood test to enable proactive non-invasive serial assessment of kidney transplant recipients with stable renal function.•In this study, simultaneous blood tests and clinical assessments were performed in 192 patients from 7 transplant centers to evaluate TruGraf v1 and the results show that TruGraf v1 can potentially support a clinical decision enabling unnecessary surveillance biopsies with high confidence, making it an invaluable addition to the transplant physician's toolkit for managing patients.