Through an early access program, Transplant Genomics Inc (TGI), Brookline, Mass, has provided its TruGraf blood test for kidney transplant recipients to a select group of four US transplant centers.

The 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. According to the company, diagnostic gene expression profiling represents the first major advance in kidney transplant recipient management in decades.

Roy First, MD, Transplant Genomics.

Roy First, MD, Transplant Genomics.

“At TGI, our goal is to extend graft and patient lives by enabling personalized immunosuppression,” says Roy First, MD, chief medical officer at TGI. “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.”

Initial institutions and team leaders involved in the early access program include:

  • California Pacific Medical Center, San Francisco, led by Ram Peddi, MD, director of kidney transplant research in the department of transplantation.
  • Henry Ford Health System, Detroit, led by Anita Patel, MD, medical director of kidney transplantation.
  • Houston Methodist Hospital, led by Osama Gaber, MD, director of the Houston Methodist JC Walter Jr Transplant Center.
  • University of Wisconsin, led by Didier Mandelbrot, MD, medical director of kidney and pancreas transplantation.

Under the program, partners receive access to TruGraf testing along with a high level of logistical support.

Ram Peddi, MD, California Pacific Medical Center.

Ram Peddi, MD, California Pacific Medical Center.

“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,” Peddi says. “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.”

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 early access program in the upcoming months.

For more information, visit Transplant Genomics.