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Clinical Utility Study Indicates Potential for TruGraf™ Test to Replace Surveillance Biopsies in Kidney Transplant Recipients with Stable Renal Function

MANSFIELD, MA – Transplant Genomics Inc. (TGI), a molecular diagnostics company committed to improving organ transplant outcomes, has published a manuscript titled “Clinical Utility of Peripheral Blood Gene Expression Profiling of Kidney Transplant Recipients to Assess the Need for Surveillance Biopsies in Subjects with Stable Renal Function” in the Journal of Transplantation Technologies & Research. This report describes use of the TruGraf blood test on 125 kidney transplant patients with known stable renal function, at the same time as each had surveillance biopsies confirming normal histology. The TruGraf blood test accurately identified nearly 90% of patients who were adequately immunosuppressed and could have avoided being subjected to an invasive, risky and expensive surveillance biopsy. In this retrospective data modeling study TruGraf testing on blinded samples resulted in an overall sensitivity of 88% with a positive predictive value (PPV) of 86%, indicating the clinical utility TruGraf testing could provide to kidney transplant patients with stable serum creatinine levels.

Surveillance “protocol” biopsies are used by transplant centers to identify the 20% to 25% of kidney transplant recipients who appear stable but are silently rejecting, experiencing sub-clinical acute rejection (subAR). Protocol biopsies are invasive, may result in post-operative complications, are costly to the healthcare system, and approximately 80% of these procedures reveal normal histology.

“TruGraf is the first test capable of providing information to physicians that a patient with stable renal function and no clinical signs of rejection is indeed healthy, and does not need an invasive and costly surveillance biopsy. The results of this study indicate clinical utility of TruGraf testing as a non-invasive alternative to surveillance “protocol” biopsies to confirm immune quiescence in kidney transplant recipients with stable renal function,” stated Dr. M. Roy First, Chief Medical Officer at TGI and lead author on this study.

A copy of the study can be obtained from the Transplant Genomics’ website at http://www.transplantgenomics.com, or through the following link to the Journal of Transplantation Technologies & Research on-line publication: https://www.omicsonline.org/ArchiveJTTR/articleinpress-transplantation-technologies-research-open-access.php

 

MEDIA CONTACTS:

Darren Lee, Transplant Genomics Inc., at 781-454-6523 or dlee@transplantgenomics.com

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. www.transplantgenomics.com

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