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Studies Presented at American Transplant Congress Describe Validation of Noninvasive Tests for Post-Transplant Management of Kidney Graft Recipients

First Validation of a Blood-Based Signature for Subclinical Acute Rejection

Brookline, MA, April 23, 2015 — Studies by the scientific founders of Transplant Genomics Inc. (TGI) to be presented at the upcoming American Transplant Congress (ATC) May 2–6 in Philadelphia demonstrate validation of the company’s tests to support management of kidney transplant recipients. The tests are designed to detect early signs of kidney graft injury, differentiate between actionable causes and enable optimization of therapy, with the potential to extend lives and reduce costs of associated healthcare.

“These studies validate the use of our tests in both peripheral blood and biopsies to classify the immune status of kidney graft recipients,” explained Stan Rose, PhD, President & CEO of Transplant Genomics and a kidney transplant recipient himself. “The validation of the first bloodbased signature for subclinical acute rejection is an important milestone in our efforts to offer noninvasive serial monitoring of immune status in kidney transplant recipients.”

This research was funded in large part by a grant from the National Institute of Allergy and Infectious Diseases (NIAID) –, as part of the Clinical Trials in Organ Transplantation (CTOT) through a grant (U01 AI084146 – Proteogenomics for Organ Transplantation; Prediction, Diagnosis, Intervention; Principal Investigator: Michael M. Abecassis MD)

Study: Blood-Based Signature for Subclinical Acute Rejection

Validation of a Peripheral Blood Gene Expression Profile for Subclinical Acute Rejection in Kidney Transplant Recipients – Findings from the CTOT 08 Study (1) by Dr. Sunil M. Kurian and Dr. John Friedewald and colleagues will be presented on Monday, May 4. This study highlights the analysis of gene expression profiles in blood samples from patients with protocol biopsy proven subclinical acute rejection or clinical acute rejection, or from stable patients. A distinct gene expression profile that classifies patients with subclinical acute rejection was discovered in the peripheral blood. The expression profiles were then clinically validated in a separate sample set, where the different phenotypes were distinguished with high accuracy.

“A noninvasive test for subclinical acute rejection could reduce the need for protocol biopsies, inform the need for a ‘for cause’ biopsy and help with monitoring and adjustment of therapy,” explained Dr. Friedewald, Associate Professor of Medicine and Surgery at Northwestern University’s Feinberg School of Medicine and a transplant nephrologist at Northwestern Memorial Hospital and the Kovler Organ Transplant Center. “Our study shows the first validated blood-based signature for subclinical acute rejection and demonstrates the potential value of integrating molecular biomarkers into clinical practice to serially monitor and improve outcomes for kidney transplant patients.”

Study: Validation of Next-Generation Sequencing to Detect Subclinical Acute Rejection

Validation of Blood and Biopsy Gene Expression-Based Molecular Diagnostics for Subclinical Acute Rejection: Comparing DNA Microarrays Vs. Next-Generation RNA Sequencing (2) will be presented on Sunday, May 3. In this study, Dr. Friedewald, Dr. Kurian and colleagues substantiate RNA sequencing as an alternative data generation platform for analyzing gene expression profiles in blood and tissue from kidney transplant recipients. The data validate that gene expression signatures for subclinical acute rejection, acute rejection and transplant excellence (stable patients) can be detected as robustly with RNA sequencing as with microarrays. Next-generation sequencing has the potential to offer advantages such as reduced cost of analysis and improved throughput for sample processing. Development of kits enabling assay performance on local lab-based sequencing systems could facilitate expansion of test use worldwide.

TGI Symposium at ATC

During ATC, TGI is sponsoring an educational luncheon symposium, Towards Clinical Use of Genomic Biomarkers in Transplantation, on Monday, May 4, from 12:45 to 2:00 pm ET at the Philadelphia Marriott Downtown. Meeting attendees can access information or register at

About Transplant Genomics Inc.

Transplant Genomics Inc. (TGI) is a molecular diagnostics company committed to improving organ transplant outcomes, with an initial focus on kidney transplant recipients. Working with the transplant community, TGI is commercializing a suite of tests enabling diagnosis and prediction of transplant recipient immune status. Test results will support clinicians with information to optimize immunosuppression therapy, enhance patient care and improve graft survival. Test services are offered through TGI’s CLIA lab in Pleasanton, CA.

  1. Friedewald J, Kurian S, Gelbart T, Salomon D, Abecassis M. Validation of a peripheral blood gene expression profile for subclinical acute rejection in kidney transplant recipients – findings from the CTOT 08 study. Presentation at American Transplant Congress, May 4, 2015.
  2. Kurian S, Friedewald J, Harrison F, et al. Validation of a blood and biopsy gene expression-based molecular diagnostics for subclinical acute rejection: comparing DNA microarrays vs. next-generation RNA sequencing. Presentation at American Transplant Congress, May 3, 2015.

Ed Stevens