FDA Approves PleximmuneTM for Personalized Prediction of Transplant Rejection in Children

Pittsburgh, PA, September 11, 2014 --(PR.com)-- Today the FDA announced approval of PleximmuneTM, a blood test from the Pittsburgh-based biotech company Plexision. This test predicts acute cellular rejection of transplanted livers and intestines in children. PleximmuneTM is a first-in-class test to determine a personalized rejection-risk index using cell-based technology.

The PleximmuneTM blood test predicts acute cellular rejection with an overall accuracy approaching or exceeding 80 percent in the 60-day period following the test. Test performance has been established in research blood samples from more than 200 children who received liver or intestine transplantation at the Children’s Hospital of Pittsburgh of the University of Pittsburgh Medical Center.

PleximmuneTM fulfills an unmet need to measure rejection-risk non-invasively after liver or intestine transplantation. Half of all transplant recipients experience acute cellular rejection over their lifetimes. Repeated episodes lead to gradual loss of organ function. Therefore, estimating the risk of rejection is an essential component of recipient care. Rejection-risk is currently estimated with clinical information including blood tests, which can measure organ function; however, rejection is not always accompanied by abnormal blood tests. Additionally, blood tests may provide incomplete information about organ function.

Plexision (www.plexision.com) develops personalized test systems for transplantation, immunological disorders and drug development using patented technology licensed exclusively to Plexision by the University of Pittsburgh. PleximmuneTM is designated a Humanitarian Use Device by the FDA’s Office for Orphan Products and has been approved under the Humanitarian Device Exemption program of the FDA for rare disease populations. The test is performed on samples shipped to Plexision’s CLIA-certified reference laboratory in Pittsburgh. Plexision’s Chief Executive Officer, Ashok Reddy, says, “Understanding the developing immune systems of children who receive lifelong antirejection medicines after transplantation can be challenging. We see such challenges of unique patient populations as opportunities for personalized diagnostics.”

To learn more about Plexision and its products, please visit www.plexision.com, email info@plexision.com, call 412-224-2507 or fax a request to 412-224-2776.