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Expert Rev Mol Diagn. 2016;16(4):387-93. doi: 10.1586/14737159.2016.1139455. Epub 2016 Feb 16.

Profile of the Pleximmune blood test for transplant rejection risk prediction.

Author information

1
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.
2
b Plexision Inc ., Pittsburgh , PA , USA.
3
c Tissue Typing Laboratory, Department of Pathology , Children's Hospital of Pittsburgh of UPMC , Pittsburgh , PA , USA.

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.

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

PMID:
26760313
PMCID:
PMC4965161
DOI:
10.1586/14737159.2016.1139455
[Indexed for MEDLINE]
Free PMC Article

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