Background: TruGraf is a blood test that measures gene expression signatures in kidney transplant recipients,\nproviding information on adequacy of immunosuppression. Signatures derived from peripheral blood using DNA\nmicroarrays have been internally and externally validated in two populations of transplant recipients: (i) patients\ndesignated as TX (ââ?¬Å?Transplant eXcellenceââ?¬Â) - stable serum creatinine and normal biopsy, indicative of immune\nquiescence, and (ii) patients designated as not-TX (renal dysfunction and/or histological abnormalities). The test is\nintended for use in subjects with stable renal function as an alternative to protocol biopsies.\nMethodology: Simultaneous blood tests and transplant biopsies were performed in 169 patients. The molecular\nlaboratory was blinded to renal function and biopsy results.\nResults: Biopsy-confirmed clinical phenotype was TX (105 cases), not-TX (64). Renal function was stable in 125\nsubjects (105 TX, 20 not-TX). Positive predictive value of TruGraf for detecting TX was 86% and 105/125 (84%) had\na normal biopsy result.\nSignificance of study: In subjects with stable renal function, TruGraf blood test result of TX corresponded to\nbiopsy findings in 88% of cases. Results indicate that had the blood test been run in place of surveillance biopsies,\n107/125 (86%) of patients with stable renal function may have avoided an invasive biopsy and 92/105 (88%) of\nthese patients with biopsy-confirmed TX may have avoided a biopsy for a negative result.
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