ATC Abstracts

American Transplant Congress abstracts

  • Home
  • Meetings Archive
    • 2022 American Transplant Congress
    • 2021 American Transplant Congress
    • 2020 American Transplant Congress
    • 2019 American Transplant Congress
    • 2018 American Transplant Congress
    • 2017 American Transplant Congress
    • 2016 American Transplant Congress
    • 2015 American Transplant Congress
    • 2013 American Transplant Congress
  • Keyword Index
  • Resources
    • 2021 Resources
    • 2016 Resources
      • 2016 Welcome Letter
      • ATC 2016 Program Planning Committees
      • ASTS Council 2015-2016
      • AST Board of Directors 2015-2016
    • 2015 Resources
      • 2015 Welcome Letter
      • ATC 2015 Program Planning Committees
      • ASTS Council 2014-2015
      • AST Board of Directors 2014-2015
      • 2015 Conference Schedule
  • Search

A Novel Prospective Validation Trial Of Multiple Blood-based RNA Signature Assays Pre And Post Kidney Transplant To Predict Rejection

L. Gallon1, P. O'Connell2, A. Chang3, M. Donovan4

1Northwestern Univ, Chicago, IL, 2Westmead Inst, Sydney, Australia, 3Univ of Chicago, Chicago, IL, 4Verici Dx, Franklin, TN

Meeting: 2022 American Transplant Congress

Abstract number: 9045

Keywords: Gene expression, Multicenter studies, Prediction models, Rejection

Topic: Basic & Clinical Science » Basic & Clinical Science » 74 - Clinical Trials

Session Information

Session Name: Clinical Trials

Session Type: Poster Abstract

Date: Saturday, June 4, 2022

Session Time: 5:30pm-7:00pm

 Presentation Time: 5:30pm-7:00pm

Location: Hynes Halls C & D

*Purpose: The accuracy and utility of clinically defined and analytically validated predictive biomarkers in kidney transplantation is limited. We leveraged prior feasibility blood-RNA studies to develop a highly sophisticated next-generation sequencing (NGS) platform which interrogates the immunologic profile of kidney transplant patients.

*Methods: The approach has been established in a highly regulated CLIA environment to provide clinical grade assays. By applying algorithm-based clinical decision trees, two discrete gene sets predicting the likelihood of both pre- and post-transplant rejection were developed. The outcome of each assay is the generation of a risk score and a machine learning algorithm-derived cut-off which classifies patients’ risk of early acute or clinical / subclinical rejection. To clinically validate both assays we designed a novel prospective multi-site (14 transplant centers), multi-country (i.e. US, Spain, France, Italy, Australia) observational trial which correlates the 2 unique RNA biomarker signatures with the histopathology and BANFF criteria of either a protocol or for cause kidney biopsy as the gold standard for evidence of transplant rejection (clinical / subclinical acute rejection).

*Results: To date, 322 patients have been enrolled which completes both pre- and post-transplant assay requirements. A target time for acute clinical and subclinical rejection is 6 months; however, all patients will be followed for 24 months to validate a third assay for predictive risk of kidney fibrosis. After 24 months, participants will be monitored through registry data. To harmonize the microscopic attributes of the kidney tissue specimens, a central pathology review of all diagnostic biopsies will be incorporated both independently and in conjunction with site-specific diagnoses.

*Conclusions: The overall approach including an all-comers, multi-center, multi-country design coupled with the rigor of an NGS assay allows for the generation of performance characteristics, including accuracy and precision, which should better inform medical management of kidney transplant patients in a more personalized and predictive manner. This unique design of correlating a quantitative blood-based transcriptomic signature with a rejection phenotype based on histopathology in the kidney biopsy represents a level of evidence which currently does not exist in biomarker transplant biology. We anticipate an interim performance review of both assays in Q2 2022.

  • Tweet
  • Email
  • Print

To cite this abstract in AMA style:

Gallon L, O'Connell P, Chang A, Donovan M. A Novel Prospective Validation Trial Of Multiple Blood-based RNA Signature Assays Pre And Post Kidney Transplant To Predict Rejection [abstract]. Am J Transplant. 2022; 22 (suppl 3). https://atcmeetingabstracts.com/abstract/a-novel-prospective-validation-trial-of-multiple-blood-based-rna-signature-assays-pre-and-post-kidney-transplant-to-predict-rejection/. Accessed May 9, 2025.

« Back to 2022 American Transplant Congress

Visit Our Partner Sites

American Transplant Congress (ATC)

Visit the official site for the American Transplant Congress »

American Journal of Transplantation

The official publication for the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS) »

American Society of Transplantation (AST)

An organization of more than 3000 professionals dedicated to advancing the field of transplantation. »

American Society of Transplant Surgeons (ASTS)

The society represents approximately 1,800 professionals dedicated to excellence in transplantation surgery. »

Copyright © 2013-2025 by American Society of Transplantation and the American Society of Transplant Surgeons. All rights reserved.

Privacy Policy | Terms of Use | Cookie Preferences