Thursday, June 20, 2013

Now in Canada - Blood test identifies probability of rejection in heart recipients

MISSISSAUGA, ONTARIO and BRISBANE, CALIFORNIA -- (Marketwired) -- 06/20/13 -- CML HealthCare Inc. (TSX:CLC) (the "Company" or "CML HealthCare"), a leading provider of medical diagnostic services in Canada, and XDx, Inc. ("XDx"), a leading U.S. molecular diagnostics company focused on high clinical impact blood tests for transplantation and autoimmune diseases, today entered into an exclusive licensing agreement that provides CML HealthCare with exclusive rights, initially in Ontario, to AlloMap, XDx's flagship diagnostic blood test used by physicians to identify heart transplant recipients who have a low probability of acute cellular rejection. The agreement also provides the Company with the option to extend the distribution and marketing rights to AlloMap across Canada.
AlloMap has been marketed by XDx in the United States since 2005 and is CLIA certified, FDA cleared and CE marked. It will be available in Ontario in late summer 2013.
"We are very pleased to be the exclusive partner of XDx for commercialization of AlloMap initially in Ontario with an option to extend our relationship to the rest of Canada. Making a high value, patient focused test available to the heart transplant community is another demonstration of our commitment to bring new and innovative clinical diagnostics to Canadians. We are confident that the medical benefits of AlloMap and its success in the United States should lead to a rapid adoption in Canada," said Thomas Wellner, President and CEO, CML HealthCare.
"XDx has been a pioneer in high value, high clinical impact molecular diagnostics in the United States. The agreement reached with CML HealthCare will provide great benefit for heart transplant recipients throughout Canada. With our strong body of peer reviewed clinical evidence--demonstrated through four major clinical studies in the US, Europe and Canada--CML can build on the tremendous efforts XDx have invested in AlloMap. The strengths of CML HealthCare as a leader in clinical diagnostic services in Canada convinced us to grant the exclusive license," said Peter Maag, CEO of XDx.
AlloMap testing will be performed by XDx in its CLIA laboratory in Brisbane, California. There are approximately 165 heart transplants performed annually in Canada. Currently, as part of the overall management of heart transplant patients, multiple invasive heart biopsies are performed, especially during the early years post-transplant. In comparison, the AlloMap Test is a simple, non-invasive blood test.
About AlloMap
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 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 in the United States since 2005. AlloMap was cleared by the U.S. Food and Drug Administration in 2008 and was CE marked in the European Union in 2011. Use of AlloMap is also included in the International Society for Heart and Lung Transplantation (ISHLT) Practice Guidelines, published in August 2010, the worldwide standard for the care of heart transplant patients.
About XDx, Inc.
Founded in 2000, XDx, Inc. is a molecular diagnostics company based in Brisbane, CA, USA. XDx applies modern genomics technologies to the development of molecular diagnostic assays that translate a patient's immune status into clinically actionable information.
XDx has one marketed product, AlloMap® Molecular Expression Testing, and other products under development. The proprietary molecular expression technology used by XDx to develop AlloMap testing for heart transplant patient management may be applicable to the post-transplant management of recipients of other organs. The application of gene expression testing to other diseases that involve the activity of the immune system, such as autoimmune and chronic inflammatory diseases, is also being explored.

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