Plexison announced that the Food and Drug Administration (FDA) has approved Pleximmune, a first-in-class blood test to predict acute cellular rejection of transplanted livers and intestines in children.
Pleximmune measures the inflammatory response of T-cytotoxic memory lymphocytes to donor cells and generates a numeric score (immunoreactivity index). This index is compared with a rejection-risk threshold developed from prior research to assign risk.
The approval is based on test performance in research blood samples from over 200 children receiving liver or intestine transplantation at the Children’s Hospital of Pittsburgh of the University of Pittsburgh Medical Center. Pleximmune predicted acute cellular rejection with an overall accuracy approaching or exceeding 80% in the 60-day period post-test.
For more information visit Plexison.com.