XDx Announces Anthem Blue Cross and Blue Shield Has Determined That AlloMap® Is Medically Necessary for Heart Transplant R

Demonstrates Increased Payer Coverage for AlloMap

BRISBANE, Calif.--(BUSINESS WIRE)-- XDx, Inc., a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value non-invasive gene expression tests to monitor immune-mediated conditions, today announced that Anthem Blue Cross and Blue Shield, one of the nation's leading providers of healthcare insurance, has determined that AlloMap® is “medically necessary” as a non-invasive method of determining the risk of rejection in heart transplant recipients. Anthem acknowledges the clinical utility of AlloMap by covering the test for eligible patients.

“We are pleased by Anthem’s decision, which we believe further underscores the growing recognition of the important role AlloMap can play in the management of heart transplant recipients,” said Pierre Cassigneul, president and CEO of XDx. “The continued acceptance and adoption of AlloMap by health insurance leaders like Blue Cross and Blue Shield provide us with the opportunity to expand our impact and improve stable patients’ quality of life by reducing the number of surveillance biopsies.”

In the United States, there are about 2,100 heart transplants performed each year and approximately 20,000 living heart transplants 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 typically 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.

For further Anthem Blue Cross and Blue Shield policy guidance and details, please reference medical policy TRANS.00025 Laboratory Testing as an Aid in the Diagnosis of Heart Transplant Rejection.

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.

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. 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.


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