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 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 - an integer ranging from 0 to 40. Compared with patients in the same post-transplant period, the lower the score, the lower the probability of acute cellular rejection at the time of testing.
The AlloMap Report is delivered via fax to the treating physician, who interprets it in light of the patient’s clinical assessment and other test results. After testing, XDx bills the medical center or patient's insurer directly. The AlloMap test is performed at the CLIA-certified XDx Reference Laboratory in Brisbane, California.
The AlloMap test has been available since January 2005 and was cleared by the FDA in 2008. To date, AlloMap has been ordered across 90 U.S. transplant centers.