The prospective, multi-center trial was designed to evaluate the clinical usefulness of a multi-gene molecular expression assay test developed to identify the "quiescent" state after heart transplantation and to determine the assay's ability to predict clinical outcomes. A major challenge physicians face in managing transplant patients is finding the right balance of drug therapy one that suppresses the patient's immune response enough to prevent rejection of the transplanted organ, but not so much that the immune system no longer competently fights infection and cancer. With this balance reached, the immune system is "quiescent."

Analysis from the eight-center trial revealed molecular testing using peripheral leukocyte gene expression can identify the quiescent state and predict future occurrence of rejection during the first year after cardiac transplantation.

"The development of alternative, non-invasive procedures, such as gene expression-based monitoring of the immune response, may provide us with the ability to predict organ rejection and provide better post-operative care," said Mandeep Mehra, M.D. and lead investigator for the study.

"This technology has many benefits. It can be used to identify patients with acute rejection early when it is most treatable, help us better manage patients' immunosuppression regimens and provide a means to resolve uncertainties of a biopsy."

For patients, the test could mean less discomfort during the constant monitoring for rejection and prolonged transplant success. Worldwide, approximately 4,500 cardiac transplants are performed annually. The most common cause of death in the first year after transplantation is acute cardiac rejection
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Contact: Kelly Goff
kellygoff@server63.com
210-378-1980
International Society for Heart and Lung Transplantation
23-Apr-2004