BRISBANE, Calif.--(BUSINESS WIRE)--XDx, Inc., a molecular diagnostics company focused on developing and commercializing innovative, noninvasive gene expression tests to monitor immune-mediated conditions, today announced that its AlloMap® Molecular Expression Test has been CE marked in the European Union (EU) under the In Vitro Diagnostics Directive. The CE mark certifies that a product has met EU health, safety and environmental requirements, which ensure consumer safety. AlloMap is a noninvasive FDA-cleared test that has been on the market in the United States since January 2005. It 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’s CE marking is a critical accomplishment for XDx in its strategy to make AlloMap available to heart transplant patients and healthcare practitioners in the EU, and eventually in other markets around the world. The potential EU market for heart transplant surveillance monitoring is substantial and nearly identical in size to the U.S. market, with approximately 2,000 new heart transplants performed annually and 20,000 living heart transplant recipients.
“AlloMap has been well accepted in the United States as a noninvasive tool that has improved the quality of life for many patients and we are delighted to begin expanding its sales globally,” said Pierre Cassigneul, president and CEO of XDx. “Gaining a CE mark is a major step in making AlloMap available to European practitioners and patients.”
XDx, Inc., based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of noninvasive 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 noninvasive 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.