FDA Approves Blood Test Developed by UPMC Researchers to Predict Rejection in Organ Transplant Recipients

PITTSBURGH, PA - November 5, 2014 - A first-of-its-kind, personalized blood test to predict the likelihood of organ rejection in children with liver or intestine transplants has received U.S. Food and Drug Administration (FDA) approval. The test was developed by researchers at Children's Hospital of Pittsburgh of UPMC to determine a personalized rejection-risk index with cell-based technology.

Cellular rejection affects half of all transplant recipients in their lifetime. If unchecked, rejection can lead to progressive loss of function of the transplanted organ. Therefore, predicting whether rejection will occur is an essential part of the recipient's care, and has been an unmet need until recently. A biopsy is used to detect ongoing rejection, but this surgical procedure cannot predict rejection.

The research team led by Rakesh Sindhi, M.D., F.A.C.S., co-director, pediatric transplantation, at the Hillman Center for Pediatric Transplantation at Children's, began work on this test system in late 2006. The technology was licensed by the University of Pittsburgh to Plexision, a Pittsburgh-based biotech company, for development.

Pleximmune, as the test is named, predicts acute cellular rejection with an accuracy approaching or exceeding 80 percent under a variety of conditions. This performance has been established in a study involving more than 200 children who received liver or intestine transplants at Children's Hospital.

"A common theme in every encounter with our patients is an assessment of whether that child is at risk for rejection and whether this risk will be affected by the planned treatment," said Dr. Sindhi, who is also director of pediatric transplant research. "It is hoped that the information from such personalized blood tests will improve clinical decision-making and benefit patients in the long run."

"Our whole philosophy here at Children's Hospital centers on improving outcomes after transplantation and achieving the goal of a normal life for all the children we transplant," said George Mazariegos, M.D., F.A.C.S., chief, pediatric transplantation. "This test is a step toward achieving that goal. And it is doubly exciting that the research in Dr. Sindhi's lab is affecting children at the bedside so directly."

The Hillman Center for Pediatric Transplantation at Children's Hospital maintains one of the busiest and most experienced pediatric transplant centers in the United States. The center was established in 1981 under renowned transplant pioneer Thomas E. Starzl, M.D., Ph.D., as the nation's first pediatric transplant program. Children's is one of the most active transplant centers for infants, children and adolescents with referrals from all over the world. The team specializes in heart, lung, liver, intestine, multivisceral, kidney, and blood and marrow transplants, and achieves patient outcomes that rank among the world's best.

Dr. Sindhi is the inventor of technology licensed to Plexision, on which this test system is based. The University of Pittsburgh holds equity in the company; Dr. Sindhi has an unpaid consulting relationship with the company.

For more information on Dr. Sindhi and the Hillman Center for Pediatric Transplantation, visit www.chp.edu/transplant.

Andrea Kunicky, 412-692-6254, andrea.kunicky@chp.edu  

Marc Lukasiak, 412-692-7919, marc.lukasiak@chp.edu