Diaxonhit, the leading French provider of specialty diagnostic solutions, and XDx, Inc., a U.S. molecular diagnostics company focused on non-invasive tests for transplantation and autoimmune disease, announced today that they have entered into a memorandum of agreement for the exclusive license to market and perform AlloMap Molecular Expression Testing (AlloMap®) in Europe. AlloMap is XDx's flagship diagnostic blood test used by physicians to identify heart transplant recipients who have a low probability of acute cellular rejection. AlloMap has been marketed in the United States since 2005 and is CLIA certified, FDA cleared and obtained CE marking in Europe in 2011.
"We are very pleased to be the exclusive partner of XDx for marketing AlloMap in Europe. Entering into this exclusive license agreement demonstrates the ability of our new group to successfully carry out its strategy of growth and development. The medical benefits of AlloMap and its success in the United States give us confidence in a rapid adoption in Europe," said Loïc Maurel, CEO of Diaxonhit.
"XDx has been a pioneer in high value, high clinical impact molecular diagnostics in the United States. The agreement reached with Diaxonhit will have great benefit for heart transplant recipients throughout Europe. With our European CARGO II validation study completed in 2012, Diaxonhit can build on the tremendous efforts XDx has invested in AlloMap. The strengths of Diaxonhit in the field of transplantation convinced us to grant Diaxonhit an exclusive license," said Peter Maag, CEO of XDx.
Diaxonhit becomes XDx exclusive partner in Europe
Through its wholly owned subsidiary, InGen, the leader in France for marketing tests related to transplantation, Diaxonhit has a dedicated sales force and access to an extensive commercial network throughout Europe. The group will build on these assets to promote AlloMap.
In Europe, the AlloMap test will be performed centrally by an internationally recognized French laboratory that is a leader in the field of molecular immunology and histocompatibility testing. This approach will enable AlloMap testing to continue with high quality and rapid turnaround time for this important patient segment.
In return for this exclusive European license, XDx will receive an upfront payment upon signature of the definitive agreement, future royalties based on European sales, and milestone payments based on sales performance. These payments will be made in cash and Diaxonhit stock. Payment in stock will be subject to a specific resolution to be submitted to Diaxonhit's shareholders for their approval at the upcoming Annual General Meeting to be held on June 20, 2013.
Substantial progress in the field of heart transplantation
In Europe, more than 2,000 heart transplantations are performed each year. Five countries (France, Germany, Italy, Spain, and UK) perform 70% of these transplants, half of which are conducted in 25 major hospitals. The total number of heart transplant patients currently alive in Europe is estimated at more than 15,000.
Heart transplant recipients need to be routinely monitored for acute cellular rejection. Endomyocardial biopsy has been the standard procedure to accomplish this routine surveillance, although this invasive procedure creates some risk of potentially serious adverse complications and rejection grading may be uncertain due to sampling or reader variability. AlloMap rejection surveillance is based on gene expression profiling of peripheral venous blood and is recommended by the International Society for Heart and Lung Transplantation (ISHLT) as a non-invasive method to monitor recipients for heart rejection.
AlloMap, a test successfully adopted in the United States
Developed and marketed since 2005 by XDx in the United States as a CLIA certified test, AlloMap was cleared in 2008 by the U.S. Food and Drug Administration, and has gained acceptance by heart transplantation key opinion leaders to aid in the management of their patients as an alternative surveillance method. 2,000 heart transplants are performed annually in the United States in 120 medical centers, and over 90 centers have used AlloMap. To date, more than 10,000 patients have received the test in the United States. The use of AlloMap has extensive reimbursement coverage by both private and government health insurance.
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