XDx’s AlloMap® Considered ‘Medically Necessary’ by Aetna Inc. for Heart Transplant Recipients

AlloMapadded to Aetna’s clinical policy bulletin for heart transplantation

BRISBANE, Calif.--(BUSINESS WIRE)-- XDx, Inc., a molecular diagnostics company focused on noninvasive gene expression tests to monitor immune-mediated conditions, today announced that Aetna Inc., one of the nation's leading providers of health care insurance, has determined that AlloMap^® is “medically necessary” for monitoring rejection in heart transplant recipients more than one year after a heart transplant. With this determination, Aetna joins the growing list of insurers that recognize the clinical effectiveness of AlloMap molecular expression testing.

“We are pleased by Aetna’s decision and the resulting opportunity to expand our product and services offering to more patients,” said Pierre Cassigneul, president and CEO of XDx. “Recognition of AlloMap’s benefit for eligible heart transplant recipients by one of the leading providers of health care in the United States is an important validation of our tests and results. We hope to reduce the number of invasive biopsies that stable patients have to undergo post-transplant and thereby improve patients’ quality of life.”

Following heart transplants, patients typically undergo multiple endomyocardial biopsies, a highly invasive method of monitoring for post-transplant rejection. AlloMap is a simple, non-invasive blood test that can help physicians evaluate whether a patient is at low risk for heart transplant rejection. There are about 2,100 heart transplants in the United States each year and approximately 20,000 living recipients of heart transplants.

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 a 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.

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.