First Blood Test to Confirm Stability by Ruling out Silent Rejection in Kidney Transplant Recipients with Stable Renal Function

Thursday, August 9, 2018 Organ Donation News
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MANSFIELD, Mass., Aug. 9, 2018 /PRNewswire/ -- Transplant Genomics Inc. (TGI), a molecular diagnostics company committed

to improving organ transplant outcomes, is pleased to announce that Dr. John Friedewald (Northwestern Medicine) and colleagues have published a manuscript titled "Development and Clinical validity of a novel blood-based
molecular biomarker for sub-clinical acute rejection following kidney transplant " in the American Journal of Transplantation

This publication describes development and clinical validation of a novel blood gene expression profile that serves as a biomarker that can be used to test kidney transplant patients with stable renal function, providing an alternative to invasive surveillance biopsies while indicating the absence of sub-clinical acute rejection.  "Greater than 25% of kidney transplant recipients are experiencing 'silent rejection' from sub-clinical acute rejection (subAR) in the first couple of years post transplant.  Surveillance biopsies are currently the only way to identify subAR in patients with stable renal function.  The goal of this work described in this paper, supported by NIH as the Clinical Trials in Organ Transplantation 08 (CTOT08) study, was to develop and clinically validate a biomarker that could provide clinicians with a much needed, non-invasive tool to test stable patients on a relatively frequent basis without the need for an invasive surveillance biopsy," stated Dr. John Friedewald, Northwestern University Feinberg School of Medicine, Chicago, Illinois.

Transplant Genomics has an exclusive license to commercialize this test, and will expand its TruGraf® transplant testing product portfolio with a blood test based on the exciting results of the CTOT08 study.  "Surveillance biopsies are invasive, painful, may result in post-operative complications, and are costly to the healthcare system.  What's more, approximately 75% of these procedures are negative, revealing normal histology.  There is no current blood based test available to test patients with stable renal function in a relatively frequent manner.  We're thrilled to be offering this next version of the TruGraf product family.  In comparison with our original TruGraf blood test, this improved version has the added advantage for the first time being able to specifically rule out the presence of subAR in patients with stable renal function," stated Dr. Stan Rose, CEO at TGI.

A copy of the study can be viewed by following the link from the Transplant Genomics' website at,, or directly through the following link to the American Journal of Transplantation on-line publication:

MEDIA CONTACTS: Darren Lee, Transplant Genomics Inc., at 781-454-6523 or

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 immune-suppressive therapy, enhance patient care and improve graft survival. Test services are offered through TGI's CLIA lab in Pleasanton, CA.

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SOURCE Transplant Genomics Inc.

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