title: Profile of the Pleximmune blood test for transplant rejection risk prediction.
abstract: The Pleximmune™ test (Plexision Inc., Pittsburgh, PA, USA) is the first cell-based test approved by the US FDA, which predicts acute cellular rejection in children with liver- or intestine transplantation. The test addresses an unmet need to improve management of immunosuppression, which incurs greater risks of opportunistic infections and Epstein-Barr virus-induced malignancy during childhood. High-dose immunosuppression and recurrent rejection after intestine transplantation also result in a 5-year graft loss rate of up to 50%. Such outcomes seem increasingly unacceptable because children can experience rejection-free survival with reduced immunosuppression. Pleximmune test sensitivity and specificity for predicting acute cellular rejection is 84% and 80% respectively in training set-validation set testing of 214 children. Among existing gold standards, the biopsy detects but cannot predict rejection. Anti-donor antibodies, which presage antibody-mediated injury, reflect late-stage allosensitization as a downstream effect of engagement between recipient and donor cells. Therefore, durable graft and patient outcomes also require accurate management of cellular immune responses in clinical practice.
authors.affiliation: a Department of Transplant Surgery , Thomas E. Starzl Transplantation Institute, Hillman Center for Pediatric Transplantation, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center (UPMC) , Pittsburgh , PA , USA.
authors.forename: Rakesh
authors.initials: R
authors.lastname: Sindhi
authors.affiliation: a Department of Transplant Surgery , Thomas E. Starzl Transplantation Institute, Hillman Center for Pediatric Transplantation, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center (UPMC) , Pittsburgh , PA , USA.
authors.forename: Chethan
authors.initials: C
authors.lastname: Ashokkumar
authors.affiliation: a Department of Transplant Surgery , Thomas E. Starzl Transplantation Institute, Hillman Center for Pediatric Transplantation, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center (UPMC) , Pittsburgh , PA , USA.
authors.forename: Brandon W
authors.initials: BW
authors.lastname: Higgs
authors.affiliation: b Plexision Inc ., Pittsburgh , PA , USA.
authors.forename: Samantha
authors.initials: S
authors.lastname: Levy
authors.affiliation: a Department of Transplant Surgery , Thomas E. Starzl Transplantation Institute, Hillman Center for Pediatric Transplantation, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center (UPMC) , Pittsburgh , PA , USA.
authors.forename: Kyle
authors.initials: K
authors.lastname: Soltys
authors.affiliation: a Department of Transplant Surgery , Thomas E. Starzl Transplantation Institute, Hillman Center for Pediatric Transplantation, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center (UPMC) , Pittsburgh , PA , USA.
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Bond
authors.affiliation: a Department of Transplant Surgery , Thomas E. Starzl Transplantation Institute, Hillman Center for Pediatric Transplantation, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center (UPMC) , Pittsburgh , PA , USA.
authors.forename: George
authors.initials: G
authors.lastname: Mazariegos
authors.affiliation: c Tissue Typing Laboratory, Department of Pathology , Children's Hospital of Pittsburgh of UPMC , Pittsburgh , PA , USA.
authors.forename: Sarangarajan
authors.initials: S
authors.lastname: Ranganathan
authors.affiliation: c Tissue Typing Laboratory, Department of Pathology , Children's Hospital of Pittsburgh of UPMC , Pittsburgh , PA , USA.
authors.forename: Adriana
authors.initials: A
authors.lastname: Zeevi
mesh_terms: D000293:Adolescent; D015415:Biomarkers / Q000097:blood; D023201:CD40 Ligand / Q000097:blood; D002648:Child; D002986:Clinical Trials as Topic; D006084:Graft Rejection / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007422:Intestines / Q000637:transplantation; D016031:Liver Transplantation / Q000009:adverse effects; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012680:Sensitivity and Specificity
chemical_list: D015415:Biomarkers; D011933:Reagent Kits, Diagnostic; D023201:CD40 Ligand
keywords: Acute cellular rejection; CD154; Liver transplantation; T-cytotoxic memory cells; cell-based assay; children; flow cytometry; index-based; intestine transplantation; prognostic; risk of rejection