BRISBANE, Calif. -- (BUSINESS WIRE) -- XDx, Inc., a molecular diagnostics company that discovers, develops and commercializes high value, non-invasive tests to monitor immune status in transplant recipients and autoimmune diseases, announced today that Medi-Cal, the California State Medicaid Program and one of the largest insurers in the United States, is now covering AlloMap® for its beneficiaries. Medi-Cal added AlloMap as a new, covered benefit, considering the test medically necessary for the surveillance of heart transplant recipients for organ rejection. AlloMap now is covered by over 200 insurers in the United States, and more than 80% of tests performed over the past year have been reimbursed.
“The value of AlloMap consists of its ability to non-invasively determine whether a heart transplant recipient has a low probability of rejection,” stated Dr. Mario Deng, Medical Director of Heart Transplantation at Ronald Reagan UCLA Medical Center. “Utilization of AlloMap can avoid many invasive biopsies, greatly contributing to patients’ quality of life.”
“Medi-Cal’s favorable decision is another milestone, contributing significantly to coverage of the large majority of AlloMap tests in the U.S.,” commented Peter Maag, Ph.D., President and CEO of XDx. “We are proud that AlloMap is widely used as a surveillance tool post-heart transplantation and spares patients the inherent risks associated with periodic biopsies.”
In the United States, there are about 2,100 heart transplants performed each year and approximately 20,000 living heart transplant recipients. Advances in immunosuppression have improved the survival rates following cardiac transplantation, but the risk of acute cellular rejection persists for several years and is associated with graft loss. Heart transplant recipients often may undergo endomyocardial biopsies for years after transplantation. These invasive biopsy procedures may be associated with discomfort, inconvenience and infrequent but potentially serious risks of complications. AlloMap is a simple, non-invasive blood test that aids physicians in evaluating the risk for heart transplant rejection, and may reduce the need for biopsies for stable patients.
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 for the European Union in 2011. AlloMap is recommended for appropriate patients 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 non-invasive tests for the monitoring of transplant rejection and autoimmune diseases. The company has developed AlloMap® Molecular Expression Testing, an FDA-cleared test, which provides transplant physicians with a tool to aid in the determination of the probability of acute cellular rejection for post-cardiac transplant patient management. AlloMap is marketed directly by XDx in the United States and has received marketing authorization in the European Union. Some of the AlloMap technology may be applicable to other conditions that involve transplant rejection and diseases that affect the immune system, and XDx is currently developing a lupus flare predictor test in collaboration with LabCorp. XDx’s non-invasive technology offers the potential to decrease healthcare costs and improve the quality of life for patients with a variety of life-threatening or life-altering immune-mediated diseases. For more information, please visit: www.xdx.com.