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Transplant Genomics Announces First Four Transplant Centers Participating in TruGraf Early Access Program

Brookline, MA, December 17, 2015 – Transplant Genomics Inc. (TGI) is a molecular diagnostics company committed to improving kidney transplant outcomes through tests that support physician decisions on personalized immunosuppression. The company’s TruGraf™ blood test relies on analysis of gene expression profiles to detect molecular signatures indicative of acute rejection, differentiating this clinical phenotype from nonimmune causes of dysfunction in kidney transplant recipients.

The current method for monitoring kidney graft recipients involves measuring serum creatinine levels—an insensitive late-trailing indicator of kidney damage already done, drug levels—known to have poor correlation with both rejection and nonimmune dysfunction, and/or performing surveillance biopsies, which are invasive, expensive and ill-suited to frequent and routine serial monitoring. Diagnostic gene expression profiling in general, and TruGraf in particular, represents the first major advance in kidney transplant recipient management in decades.

Following many years of scientific development and validation, TGI today announced that the company’s TruGraf blood tests for kidney transplant recipients will be provided for use by four transplant centers through an early access program (EAP). The initial participants in the program are:

  • California Pacific Medical Center, led by Ram Peddi, MD, Director, Kidney Transplant Research, Department of Transplantation
  • Henry Ford Health System, led by Anita Patel, MD, Medical Director, Kidney Transplant
  • Houston Methodist Hospital, led by Osama Gaber, MD, Director, Houston Methodist J.C. Walter Jr. Transplant Center; J.C. Walter Jr. Distinguished Endowed Chair
  • University of Wisconsin, led by Didier Mandelbrot, MD, Medical Director, Kidney and Pancreas Transplantation

Under the EAP, partners receive access to TruGraf testing along with a high level of logistical support. Dr. Ram Peddi, Director of Kidney Transplant Research at California Pacific Medical Center in San Francisco, commented that “there is a distinct need for a minimally invasive blood test to manage kidney transplant recipients and to monitor patients in order to detect early signs of rejection prior to the development of kidney dysfunction. We are enthusiastic about working with Transplant Genomics on the clinical application of gene expression profiles in the hope that the TruGraf test will represent a major step towards this much needed goal.”

“At TGI, our goal is to extend graft and patient lives by enabling personalized immunosuppression. Our early access partners are the first clinicians to use TruGraf in a clinical environment. We’re thrilled to be working with these centers that will have the opportunity to use the TruGraf blood test to support decisions regarding immunosuppressive management of kidney transplant patients,” said Dr. Roy First, Chief Medical Officer of Transplant Genomics.

Additional tests designed to be used serially to diagnose and treat subclinical episodes of rejection are in the final stages of development and validation and will be made available through the EAP in the upcoming months.

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 immunosuppressive therapy, enhance patient care and improve graft survival. Test services are offered through TGI’s CLIA lab in Pleasanton, CA.

Ed Stevens