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XDx Announces Highmark's Coverage of AlloMap® for Monitoring Heart Transplant Rejection

Wed, 11/09/2011 - 4:41am
BRISBANE, Calif.--(BUSINESS WIRE)--XDx, Inc., a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value non-invasive diagnostic tests to monitor immune-mediated conditions, today announced that Highmark Inc., an independent licensee of the Blue Cross Blue Shield Association, is now covering AlloMap® for its beneficiaries. Highmark considers AlloMap "medically necessary" for monitoring heart transplant rejection, recognizing the clinical benefits of a non-invasive method for managing rejection in stable heart transplant recipients. AlloMap now is covered for approximately two-thirds of the United States heart transplant population.

"The addition of AlloMap testing has improved our ability to provide quality care to heart transplant patients," states Dr. Srinivas Murali, Medical Director of the Cardiovascular Institute at West Penn Allegheny Health System in Pittsburgh. Dr. Murali is a leading expert in the treatment of heart failure and helps direct one of the nations preeminent heart transplantation programs at Allegheny General Hospital.

Pierre Cassigneul, President and CEO of XDx, commented, "We are very pleased with Highmarks favorable coverage decision. They join the already 200+ insurers acknowledging the clinical benefits of AlloMap, including sparing stable patients the inherent risks associated with 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. 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.

About AlloMap® Molecular Expression Technology

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 since 2005. AlloMap was cleared by the U.S. Food and Drug Administration in 2008 and was CE marked for the European Union in April 2011. Use of AlloMap is also included in the International Society of Heart and Lung Transplant (ISHLT) Practice Guidelines, published in August 2010, the worldwide standard for the care of heart transplant patients. Approximately 66% of the United States heart transplant population is covered for AlloMap.

About XDx

XDx, Inc., based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of non-invasive gene expression-based 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. Some of the AlloMap technology developed and implemented by XDx in heart transplant patient management may be applicable to other conditions that involve transplant rejection and diseases that affect the immune system. XDxs 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.

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