XDx Inc. announced that its AlloMap Molecular Expression Test has been CE marked in the European Union (EU) under the IVD 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.”