AlloMap molecular expression testing, developed and commercialized by CareDx, formerly known as XDx, is a gene expression profiling test to identify heart transplant recipients with a low probability of one type of transplant rejection. The test is performed on a blood sample, providing a non-invasive test to help manage the care of patients post transplant. Prior to the availability of this test, the primary method for managing heart transplant rejection was the invasive technique of endomyocardial biopsy.
AlloMap was cleared by the U.S. Food and Drug Administration (FDA) in 2008 as a Class II Medical Device.[1] It is available only from the CareDx Reference Laboratory in Brisbane, CA.
The use of the test is described in the recommendations for the non-invasive monitoring of acute heart transplant rejection in the first evidence-based clinical practice guidelines for the care of heart transplant recipients issued by the International Society of Heart and Lung Transplantation.[2]
References
- ^ http://www.accessdata.fda.gov/cdrh_docs/reviews/K073482.pdf
- ^ Costanzo, MR; Costanzo, MR; Dipchand, A; Starling, R; Anderson, A; Chan, M; Desai, S; Fedson, S; Fisher, P (2010). "The International Society of Heart and Lung Transplantation Guidelines for the care of heart transplant recipients". The Journal of Heart and Lung Transplantation. 29 (8): 914–56. doi:10.1016/j.healun.2010.05.034. PMID 20643330.
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