Profile of the Pleximmune blood test for transplant rejection risk prediction. (2nd April 2016)

• Record Type: Journal Article
• Authors: Sindhi, Rakesh; Ashokkumar, Chethan; Higgs, Brandon W; Levy, Samantha; Soltys, Kyle; Bond, Geoffrey; Mazariegos, George; Ranganathan, Sarangarajan; Zeevi, Adriana
• Is Part Of: Expert review of molecular diagnostics. Volume 16:Number 4(2016)
• Page Start: 387
• Page End: 393
• Publication Date: 2016-04-02
• Subjects: Acute cellular rejection -- cell-based assay -- prognostic -- Liver transplantation -- intestine transplantation -- children -- risk of rejection -- T-cytotoxic memory cells -- CD154 -- flow cytometry -- index-based; Molecular diagnosis -- Periodicals; 616.0758205
• DOI: 10.1586/14737159.2016.1139455
• Languages: English
• ISSNs: 1473-7159

Abstract

SUMMARY: The Pleximmune TM 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.