The IMAGE study is a multicenter, randomized clinical trial of 602 heart transplant patients comparing XDx’s AlloMap Molecular Expression Testing, a noninvasive rejection surveillance method utilizing gene expression profiling testing, to routine endomyocardial biopsy surveillance to monitor acute cellular rejection in cardiac transplant recipients.

Xdx said that the comparative effectiveness research study was designed to demonstrate the non-inferiority of clinical outcomes of heart transplant recipients managed with the AlloMap test compared with conventional endomyocardial biopsy.

AlloMap Molecular Expression Testing is a gene expression test that uses a simple, noninvasive method of blood sample collection and can be used to reliably indicate the low probability of acute cellular rejection in stable heart transplant recipients. AlloMap testing measures the expression levels of 20 specific genes in the blood.

Xdx also said that the combined expression of the genes, represented as an AlloMap test score, can help a physician evaluate whether a patient is at low risk for rejection when used together with standard clinical assessment. AlloMap, performed in the XDx CLIA certified laboratory, has been commercially available since 2005 and was cleared by the FDA in 2008.

Based in Brisbane, California, Xdx is a molecular diagnostics company focused on noninvasive tests for the monitoring of immune-mediated conditions.