International Society For Heart & Lung Transplantation And XDx Announce Results Of IMAGE Study Demonstrating Non-Inferiority Of AlloMap(R) To Routine Biopsy For Routine Surveillance After Heart Transplantation

CHICAGO, April 22 /PRNewswire/ -- The International Society for Heart & Lung Transplantation (ISHLT) and XDx, Inc., a molecular diagnostics company focused on noninvasive gene expression tests for the monitoring of immune-mediated conditions, today announced results from the Invasive Monitoring Attenuation through Gene Expression (IMAGE) clinical trial.

The IMAGE results were presented during a plenary session at the ISHLT 30th Anniversary Meeting & Scientific Sessions in Chicago and coincide with publication in the New England Journal of Medicine. The Journal is publishing the study today online as an "early release" to coincide with the data presentation at the ISHLT meeting and will follow with publication in the June 17, 2010, print edition.

The 602-patient IMAGE trial demonstrated that XDx's AlloMap® Molecular Expression Testing, a noninvasive gene expression test used to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection at the time of testing in conjunction with standard clinical assessment, was non-inferior to conventional endomyocardial biopsy for monitoring post-transplant patients with respect to clinical outcomes. The study also showed the use of AlloMap as part of overall patient management resulted in significantly fewer biopsies compared to the current standard of routine biopsies.

"The IMAGE trial is the first study in the field of cardiac transplantation that evaluates patient outcomes associated with the use of a biomarker for clinical decision making," said Michael Pham, M.D., M.P.H., the study's co-lead investigator and a transplant cardiologist at the Stanford University Medical Center and Veterans Affairs Palo Alto Health Care System. "In this large randomized trial involving over 600 heart transplant recipients who were at least six months post-transplantation at the time of their participation, we found that patients undergoing rejection monitoring using a gene-expression profiling test of peripheral blood specimens underwent significantly fewer biopsies and were more satisfied with the biopsy-minimization approach compared to patients who underwent routine biopsies at regular intervals. Patients in both groups experienced similar rates of clinically apparent rejection, cardiac dysfunction, death or the need for a second transplant."

Each year in the United States, about 2,200 individuals receive heart transplants. Advances in immunosuppression have improved one-year survival rates to nearly 90 percent following cardiac transplantation, but the risk of acute cellular rejection persists for several years post-transplantation and is associated with graft loss. Heart transplant recipients typically undergo 12 biopsies in the first year following transplantation and four biopsies in the second year.  Many centers continue surveillance biopsies for several more years.  Invasive biopsy procedures may be associated with discomfort, inconvenience and infrequent but potentially serious risks of complications.

AlloMap was cleared by the U.S. Food and Drug Administration (FDA) in 2008 to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection at the time of testing in conjunction with standard clinical assessment. XDx has submitted the results of the IMAGE trial to the FDA for a label extension for AlloMap compared with biopsy.

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