Key result
AlloMap gene expression profiling was previously shown to be non-inferior to endomyocardial biopsies for detecting clinical rejection and improved patient satisfaction.
Why the study?
Does the AlloMap GEP biomarker test safely replace endomyocardial biopsies for monitoring acute cellular rejection in cardiac allograft recipients?
Does the AlloMap GEP biomarker test safely replace endomyocardial biopsies for monitoring acute cellular rejection in cardiac allograft recipients?
Answers are grounded in this paper and cite their sources.
The AlloMap GEP test provides a non-invasive, non-inferior alternative to endomyocardial biopsy for monitoring acute cellular rejection in heart transplant recipients.
Over the last >20 years, we have co-developed the rationale for the first diagnostic and prognostic leukocyte gene expression profiling (GEP) biomarker test in transplantation medicine that gained US-FDA-regulatory clearance and international evidence-based medicine guideline acceptance to rule out moderate/severe acute cellular cardiac allograft rejection without invasive endomyocardial biopsies (EMB). Based on this test, a non-invasive clinical algorithm was implemented since 2005. After clinical implementation, this GEP-based monitoring in direct comparison with an EMB-based strategy was non-inferior with respect to detection of clinical rejection, defined as new onset allograft dysfunction with/without histology of ACR, re-transplantation or death, and at the same time improved patient satisfaction. Subsequently, we demonstrated the test's capacity when used as serial monitoring tool to predict these clinical rejection events. In this Personal Viewpoint article, I will discuss the various decision-making branching points that were made in the AlloMap biomarker test development to inform future genomic biomarker test development projects.
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Mario C. Deng (2017) conducted a review in Cardiac allograft rejection. AlloMap leukocyte gene expression profiling (GEP) biomarker test vs. Endomyocardial biopsies (EMB) was evaluated on Clinical rejection (new onset allograft dysfunction with/without histology of ACR, re-transplantation or death). AlloMap gene expression profiling was previously shown to be non-inferior to endomyocardial biopsies for detecting clinical rejection and improved patient satisfaction.
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