AlloMap^® Testing Overview

 

AlloMap testing is intended to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (ACR) at the time of testing in conjunction with standard clinical assessment.

 

The AlloMap test is based on standard quantitative real-time polymerase chain reaction technology (qRT-PCR) using RNA isolated from peripheral blood mononuclear cells (PBMC). A whole blood sample is collected, PBMC are isolated, lysed and the released RNA stabilized and frozen (PBMC lysate). RNA is then purified from the PBMC lysate. cDNA is subsequently generated from the RNA for use in the AlloMap test performed at the single site XDx CLIA-certified laboratory in Brisbane, CA.  

 

The AlloMap test is a panel of 20 gene assays, 11 informative and 9 used for normalization and/or quality control, which produces gene expression data used in the calculation of an AlloMap Test score. The score is reported to the ordering physician in a test report developed by XDx in accordance with CLIA reporting guidelines. The physician uses the AlloMap Test score along with standard clinical assessment to determine the status of the patient and whether additional diagnostic evaluation is necessary.

 

The AlloMap test has been available since January 2005 and has been ordered at more than 50 U.S. transplant centers.