FDA Approves Pleximmune^TM For Personalized Prediction of Transplant Rejection in Children

PITTSBURGH, Sept. 11, 2014,/PRNewswire-iReach/ -- Today the FDA announced the approval of Pleximmune^TM, a blood test from the Pittsburgh-based biotech company Plexision. This test predicts acute cellular rejection of transplanted livers and intestines in children. Pleximmune^TM is a first-in-class test to determine a personalized rejection-risk index using cell-based technology.

The Pleximmune^TM blood test predicts acute cellular rejection with 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.

To read more please go to:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=H130004