Rejection Test for Heart Transplant Patients

AlloMap testing translates the complex signals of the immune system's multiple genes and pathways into an objective, clinically actionable score that indicates a patient's risk for rejection.

The technology noninvasively monitors the immune system by measuring gene expression in the patient's peripheral blood. From a simple blood sample collected from the patient, complex gene information is extracted, analyzed, and translated into a single score that provides objective information to help doctors better manage and treat patients. AlloMap was developed by XDx, Inc. (So. San Francisco, CA, USA), a molecular diagnostics company.

A multicenter study known as the Cardiac Allograft Rejection Gene Expression Observational (CARGO) study showed that AlloMap testing can help classify patients with evidence of mild organ rejection into high and low risk groups. This is significant since there has been long-standing uncertainty over how patients with mild rejection on biopsy should be treated and managed. With the additional information supplied by AlloMap, patients at higher risk can be treated appropriately by their doctors, while low-risk patients can avoid unnecessary biopsies and immunosuppression.

The current way to monitor heart-transplant rejection is by endomyocardial biopsy. However, biopsy is a highly variable and controversial diagnostic test. Lesions called Quilty lesions are often confused with severe rejection, leading to inappropriate therapy. AlloMap testing can distinguish between transplant rejection and Quilty lesions. In addition, the data show that AlloMap molecular testing may be more reliable than pathology in assessing rejection status in patients. The findings also showed that AlloMap can be used to monitor patient response to corticosteroids.

"In addition to its value in the transplant setting, this technology offers the potential to improve the management and quality of life of patients with a variety of life-threatening diseases such as lupus and Crohn's disease,” noted Pierre Cassigneul, CEO, XDx.




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