Combination of Cell-Free DNA with Gene-Expression Profiling in the Diagnosis of Acute Rejection

Abstract

Purpose Gene expression profiling testing (GEP; AlloMap) and donor-derived cell free DNA (dd-cfDNA; AlloSure) each provide non-invasive means to detect possible heart allograft rejection, including acute cellular rejection (ACR). This report describes the performance of these two molecular diagnostic methods when used together. Methods A retrospective cohort of 26 heart transplant patients with endomyocardial biopsy-based diagnosis of grade 0 ACR were demographically matched to 27 patients with grade ≥ 2R ACR. The dd-cfDNA (%, AlloSure) and GEP (AlloMap, score 0-39) results were correlated with the biopsy-based diagnosis of ACR. Results Patients with ACR had significantly higher dd-cfDNA (0.48 vs. 0.07; P 0.2% and GEP scores > 34, we calculated a 26% sensitivity and 92% specificity, and an NPV of 98% and a PPV of 6%. When GEP Conclusion In surveillance of heart allograft recipients for rejection, consideration of dd-cfDNA levels together with GEP scores may improve patient management decisions.