AlloMap -Heart Transplant Surveillance Service
AlloMap is an innovative diagnostic test that helps identify patients with stable allograft function who have a low probability of moderate to severe acute cellular rejection (ACR) at the time of testing in conjunction with standard clinical assessment*
AlloMap allows for noninvasive surveillance of heart transplant recipients . It is used by over 90% of transplant centers, and since approval has been used over 150,000 times in nearly 30,000 patients.
- High NPV for ruling out rejection
- The Invasive Monitoring Attenuation through Gene Expression (IMAGE) study published in the New England Journal of Medicine, showed GEP-based rejection monitoring is non-inferior to routine biopsies with respect to the composite outcomes and had similar overall survival at 2 years
- Class IIa, level B recommendation by the International Society for Heart and Lung Transplantation (ISHLT) guidelines. This is the highest level of recommendation of any heart surveillance tool in the guidelines
- AlloMap is FDA cleared
- FDA’s decision summary document
The AlloMap test is derived from a panel of 20 genes, 11 informative and 9 genes used for normalization and quality control, which produces gene expression data used in the calculation of an AlloMap score . This score is associated with activity of the recipient immune system, and a lower score is associated with a quiescent allograft.