[June 27, 2013]

Diaxonhit Agrees to Commercialize in Europe the XDx AlloMap® Heart Transplant Test Following the Completion of Exclusive License Agreement

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, today announced that they have entered into a definitive exclusive license and distribution agreement to market and perform AlloMap Molecular Expression Testing (AlloMap®) in Europe.

Diaxonhit shareholders approved the issuance of warrants and stock to XDx during the annual meeting held on June 20, 2013, thereby clearing the final step for the license agreement to become effective.

Diaxonhit will promote AlloMap in Europe through its wholly owned subsidiary, InGen, the leader in France for marketing tests related to transplantation and histocompatibility testing.

For the European market, the AlloMap test will be performed centrally in the "Jean Dausset" Laboratory, a reference laboratory headed by Professor Dominique Charron, MD, PhD, a leading scientist in the field of histocompatibility and immunogenetics. This laboratory is part of the Paris Hospital Group (Assistance Publique - Hôpitaux de Paris, AP-HP) and located within the Saint-Louis Hospital in downtown Paris, France. All blood samples drawn from European heart transplant recipients will be shipped to the Jean Dausset Laboratory, where the AlloMap test will be performed. The laboratory will provide test results to the treating physician.

The test should be available to European patients in selected countries starting in early 2014.

AlloMap

AlloMap is XDx's flagship gene-expression profiling based blood test. The test is a new method for regular and non-invasive surveillance of heart transplant recipients for acute cellular rejection, thereby contributing to patient follow-up optimization. AlloMap provides unique information regarding the body's immune response to a transplanted heart in the form of an objective score.

The test has been validated in four major clinical studies in the US and Europe, involving over 2,000 heart transplant recipients and 40 clinical centers. Surveillance of heart recipients with the non-invasive AlloMap test has been shown to be as effective as surveillance with biopsies in heart transplantation clinical outcomes, based on the landmark IMAGE study published in the New England Journal of Medicine in April 2010. The International Society of Heart and Lung Transplantation recommended AlloMap testing in its guidelines for the management of heart transplant recipients in August 2010.

XDx initiated commercial AlloMap testing in the US in 2005 as a Laboratory Developed Test (LDT). In 2008 the test was FDA cleared through the 510K de novo process. It received CE marking in 2011.

To date, over 45,000 AlloMap commercial tests have been performed in more than 11,000 patients in 100 transplant centers in the US. There are approximately 2,000 heart transplantations performed annually in each of the US and European territories, with over 20,000 living heart transplant recipients in both the US and Europe. In Europe, five countries (France, Germany, Italy, Spain, and UK) constitute 70% of these transplants, half of which are conducted in 25 major hospitals⁽¹⁾.

AlloMap is priced in the same range as other high-value multivariate molecular diagnostic assays. Approximately 85% of the tests performed in US patients are currently reimbursed by a combination of private and public payers.

The "Jean Dausset" Laboratory for Histocompatibility and Immunogenetics

Originally known as the Regional Laboratory for Histocompatibility, the laboratory was founded in 1975 by Professor Jean Dausset, 1980 Nobel (News - Alert) Laureate in Medicine for the discovery of the HLA system. Since 1991, it is headed by Professor Dominique Charron and is EFI (European Federation for Immunogenetics) accredited since 1997.

The Dausset Laboratory is the largest HI (Histocompatibility - Immunogenetics) Laboratory in Europe, in charge of pre and post transplantation HI monitoring of approximately 1,625 organ-transplanted patients representing 40% of the French national organ transplants. Its activities include histocompatibility testing for organ transplantation, biobanking, research and quality insurance.

(1) Source (News - Alert) : French Biomedicine Agency

____________________

About Diaxonhit

Diaxonhit (NYSE Alternext, FR0004054427, ALEHT) is a French fully integrated leader in the in-vitro diagnostic field, involved from research to commercialization of specialty diagnostic products.

With many partnerships and a strong presence in hospitals, Diaxonhit has an extensive commercialization network. Through its affiliate, InGen, it commercializes and services, mostly under exclusivity agreements, in-vitro diagnostic kits and advanced equipment. It operates mainly in the fields of transplantation, infectious diseases and autoimmunity, product quality control and rapid tests, including Tetanus Quick Stick®, a proprietary product. InGen is the leading supplier in France of HLA tests manufactured by Thermo-Fisher/One Lambda, of which it is the largest distributor worldwide.

The group also owns a diversified portfolio of products in development, including both innovative molecular and non-molecular diagnostics, covering three main specialty areas: immuno-infection, Alzheimer's disease and cancer.

Diaxonhit headquarters are located in Paris and its affiliate in the Paris region. The Group is listed on NYSE Alternext in Paris and is part of the NYSE Alternext OSEO innovation index.

For more information, please visit: http://www.diaxonhit.com.

About XDx

XDx Inc., based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high value, non-invasive tests to monitor immune status in transplant recipients and autoimmune disease and potentially improve long-term patient outcomes. The company has commercialized AlloMap Molecular Expression Testing (AlloMap®), which aids physicians in determining the low risk of acute cellular rejection at the time of testing in stable post-cardiac transplant patients. Some of the AlloMap technology developed by XDx may be applicable to other conditions that involve transplant rejection and diseases that affect the immune system. XDx also has an active diagnostic development program in system lupus erythematosus, which includes several potential tests to address the high unmet medical need in managing this chronic disease.

For more information, please visit: www.xdx.com.

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 XDx's CLIA and CAP certified laboratory and has been commercially available in the United States since 2005. In 2008 the US Food and Drug Administration cleared AlloMap which was also CE marked in the European Union in 2011. Use of AlloMap is 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.

Disclaimer

This press release contains elements that are not historical facts including, without limitation, certain statements about future expectations and other forward-looking statements. Such statements are based on management's current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those anticipated.

In addition, Exonhit, its shareholders, and its affiliates, directors, officers, advisors and employees have not verified the accuracy of, and make no representations or warranties in relation to, statistical data or predictions contained in this press release that were taken or derived from third party sources or industry publications, and such statistical data and predictions are used in this press release for information purposes only.

Finally, this press release may be drafted in the French and English languages. In an event of differences between the texts, the French language version shall prevail.

[ Back To TMCnet.com's Homepage ]