Published: Wednesday, Apr. 10, 2013 / Updated: Wednesday, Apr. 10, 2013 11:56 AM
BRISBANE, Calif. —
XDx, Inc., a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value non-invasive tests to monitor immune status in transplant recipients and autoimmune diseases, today announced patient enrollment in the Outcomes AlloMap® Registry (OAR). AlloMap is XDx’s FDA-cleared, non-invasive blood test that aids physicians in determining a heart transplant patient’s risk of acute cellular rejection without requiring the use of endomyocardial biopsy. OAR is a multi-year, multi-center registry that will assess long-term clinical outcomes in approximately 2,000 heart transplant patients who are being managed with serial AlloMap testing as part of heart transplant rejection surveillance.
“There are few multi center trials in heart transplantation that have evaluated best clinical practices of care,” stated Manreet Kanwar, MD, FACC, Heart Failure, Pulmonary Hypertension and Transplant Cardiology at Allegheny General Hospital, Pittsburgh, Pennsylvania, a participating institution in the Registry. “The scientific community welcomes the Registry since it could potentially provide additional evidence of the long-term outcomes and benefits of surveillance in heart transplant patients.” There are approximately 2,000 new heart transplants recipients annually in the United States, and over 20,000 living heart transplant recipients with a mean life expectancy of more than 10 years.
“We look forward to partnering with XDx to further our understanding of immune surveillance and detection of rejection after heart transplantation. The AlloMap registry will go a long way to help us all achieve this goal,” stated Nasir Sulemanjee, MD, FACC, Interim Medical Director of Heart Failure, Transplant & MCSD Program, Aurora St Luke’s Medical Center.
Dr. James Yee, Chief Medical Officer of XDx, commented, “OAR represents the latest effort by XDx to further study and evaluate the impact of AlloMap testing on the long-term outcomes of heart transplant recipients. OAR builds on our extensive scientific foundation of clinical studies – CARGO, CARGO II, IMAGE, and EIMAGE – and we look forward to the results of this registry with Allegheny General Hospital, Aurora Saint Luke’s and other participating institutions.”
AlloMap Molecular Expression Testing is a non-invasive 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. AlloMap testing measures the expression levels of 20 genes from a blood sample. The combined expression of these genes is represented as an AlloMap test score. AlloMap is performed in the XDx CLIA-certified laboratory and has been commercially available in the United States since 2005. AlloMap was cleared by the U.S. Food and Drug Administration in 2008 and was CE marked in the European Union in 2011. Use of AlloMap is also included in the International Society for Heart and Lung Transplantation (ISHLT) Practice Guidelines, published in August 2010, the worldwide standard for the care of heart transplant patients.
XDx, Inc., based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high value, non-invasive tests to monitor immune status in transplant recipients and autoimmune disease and potentially improve long-term patient outcomes. The company has commercialized AlloMap Molecular Expression Testing, which aids physicians in determining the risk of acute cellular rejection in stable post-cardiac transplant patients. Some of the AlloMap technology developed by XDx may be applicable to other conditions that involve transplant rejection and diseases that affect the immune system. XDx also has an active diagnostic development program in system lupus erythematosus which includes several potential tests to address the high unmet medical need in managing this chronic disease. For more information, please visit: www.xdx.com.
via XDx Launches Multi-Year Outcomes AlloMap® Registry (OAR) for Heart Transplant Patients | Fort Mill Times – Fort Mill, SC.