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Abstract: SA-OR49

Clinical Performance Validation of Tuteva Biomarker

Session Information

Category: Transplantation

  • 2002 Transplantation: Clinical


  • Bestard, Oriol, Hospital Universitari Vall d'Hebron, Barcelona, Catalunya, Spain
  • Augustine, Joshua J., Cleveland Clinic, Cleveland, Ohio, United States
  • Gallon, Lorenzo G., Northwestern University, Evanston, Illinois, United States
  • Ansari, Mohammed Javeed, Northwestern Memorial HealthCare Corp, Chicago, Illinois, United States
  • La Manna, Gaetano, Universita degli Studi di Bologna, Bologna, Emilia-Romagna, Italy
  • Samaniego-Picota, Milagros D., Henry Ford Health System, Detroit, Michigan, United States
  • Mannon, Roslyn B., University of Nebraska System, Lincoln, Nebraska, United States

Identification of kidney allograft rejection relies mainly on monitoring methods such as proteinuria and serum creatinine. These measures may lead to assessment by biopsy. Biomarkers which correlate to or predict the presence of acute rejection are needed to support clinical management in a sensitive and less invasive manner. As a priority, biomarkers require validation in a prospective study that is reflective of the complex transplant population and for which correlation to a gold reference standard is measured. Herein we report on the validation of the Tuteva test for predictive risk of the presence of clinical / sub-clinical acute rejection in a global clinical trial.


Tuteva is a blood-RNA expression next-generation sequencing assay which interrogates the gene expression profile (GEP) of kidney transplant recipients using a signature derived in an independent cohort of transplant patients. By applying machine learning algorithm (MLA) to a discrete gene set, the assay generates a risk score interpreted by an MLA derived cut-off to predict a patients’ risk of the presence of acute rejection. The test is performed and analytically validated in a CLIA laboratory. All GEP Tuteva results were calculated in a blinded manner. The clinical study was conducted at 13 centers in the USA, Spain, Italy, France and Australia from which 151 unique kidney transplant participants were included. Each patient had blood collected at the time of surveillance or indication biopsy. All biopsies were evaluated by central pathology in blinded manner based on current BANFF criteria; borderline rejections were included in the analysis, and biopsy findings served as the outcome of ABMR, TCMR, or mixed as case definition. The event rate was 30%.


Tuteva results were reported as a continuous risk score from 1-100 with a cutpoint at 50 for separating high from low risk. This cutpoint resulted in 26% of patients in high-risk group, of which 60% showed evidence of rejection on biopsy; of the 74% of patients in the low-risk group, 80% had negative biopsy for rejection. Seven biopsies were positive for BK; 6/7 (86%) were low risk in Tuteva.


Tuteva represents an advancement in biomarker transplant biology to better inform medical management of all kidney transplant patients in a more personalized and predictive manner.


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