Skip to main content
FDA approves Pleximmune
11, Sep 2014

FDA Approves PleximmuneTM For Personalized Prediction of Transplant Rejection in Children

PITTSBURGH, Sept. 11, 2014,/PRNewswire-iReach/ -- Today the FDA announced the 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 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

 

About

Plexision develops cellular biomarkers for personalized diagnosis and drug development in solid organ transplantation and immunological disorders. We also pioneer in R&D projects centered on integrating biomarker targets in all phases of drug development, from preclinical to post-marketing. Plexision’s technology can be adapted to

  • - Assess disease risk for several immunological disorders.
  • - Predict the success of a drug for a specific patient.
  • - Develop dosing recommendations for new immunological drugs.

Our state-of-the-art laboratory is CLIA-certified and located in Pittsburgh, PA.

Contact