XDx, Inc. announced the launch of AlloMap® Molecular Expression Testing in Germany. AlloMap is XDx’s easy and convenient, non-invasive blood test that aids physicians in determining a stable heart transplant patient’s risk of acute cellular rejection without requiring the use of endomyocardial biopsy. Heart transplant specialists initiated use of AlloMap in selected German hospitals in March 2012, and XDx expects to make AlloMap available to additional German, Swiss and Austrian transplant centers throughout the second quarter of this year in the first stage of a broader European launch.
In the United States, AlloMap is FDA-cleared and has been on the market since 2005. In 2010, a study called Invasive Monitoring Attenuation Through Gene Expression (IMAGE) demonstrated that AlloMap was non-inferior to biopsy with respect to clinical outcomes, including survival and absence of graft dysfunction. In addition, the study showed a reduction in the use of biopsies by 75% on average. Patients also gave a higher satisfaction rating to AlloMap than biopsy for the method used for detecting rejection. Based on these results, AlloMap testing is recommended in the practice guidelines of the International Society for Heart and Lung Transplantation (ISHLT).
In April 2011, AlloMap received a CE mark in the European Union under the In Vitro Diagnostics Directive. Findings from a European study (CARGO II) of AlloMap will be presented at the ISHLT’s 32nd Annual Meeting & Scientific Sessions being held April 18-21, 2012 in Prague, Czech Republic. CARGO II was designed to further validate results from the landmark multi-center, prospective, validation study known as the Cardiac Allograft Rejection Gene Expression Observational (CARGO) study completed by XDx in the US.
Pierre Cassigneul, President and CEO of XDx, said, “We are excited to initiate the European AlloMap launch in Germany, which represents the largest heart transplant market in the EU, which overall is similar in size to the US market. Closely following the launch in Germany, we will soon begin making AlloMap available in Switzerland and Austria. By next year, we anticipate expanding our reach to additional large European markets.”
Jörg Stypmann, M.D., PhD, transplant cardiologist in the Department of Cardiology and Angiology of the University Hospital Münster, Germany, commented, “Heart transplant recipients must be regularly monitored for acute cellular rejection, and currently in our institution they undergo up to 15 invasive, protocol biopsy procedures in their lifetime. There is a great clinical need to determine a patient’s individual risk of rejection in order to spare them so many uncomfortable procedures, which also involve moderate risk of adverse events. We think that AlloMap, a non-invasive test with its high negative predictive value, can provide a much-needed alternative strategy to monitor effectiveness of immunosuppressive therapy during the first year after heart transplantation and in the longer term. AlloMap also can potentially reduce the number of right ventricular biopsies in stable patients.”