Newly approved blood test predicts organ transplant rejection in children

FDA has approved a first-of-its-kind, personalized blood test to predict the likelihood of organ rejection in children with liver or intestine transplants (Pleximmune). 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.

Pleximmune predicts acute cellular rejection with an accuracy approaching or exceeding 80% under a variety of conditions.

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 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.

The test’s 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 Rakesh Sindhi, MD, FACS, co-director, pediatric transplantation, at the Hillman Center for Pediatric Transplantation at Children’s. Dr Sindhi, who is also director of pediatric transplant research, led the Pleximmune research team. “It is hoped that the information from such personalized blood tests will improve clinical decision-making and benefit patients in the long run.”

“This is an interesting laboratory test,” said FormularyWatch advisor James M. Wooten, PharmD, associate professor, department of medicine, section of clinical pharmacology, University of Missouri-Kansas City.

“What is unclear is exactly how hospitals will use the test," Dr Wooten said. "Is it used post-transplant to predict if a rejection episode is probably or is it used to predict the potential incidence of rejection pre-transplant? Potentially, the test could dictate which types of immunosuppressants should be utilized in specific patients.”

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