- US - Europe AlloMap Symposium
- Four new clinical abstracts highlighting the clinical utility of AlloMap
Paris, May 5, 2014 (GLOBE NEWSWIRE) -- Diaxonhit (Alternext : ALEHT) sponsored and organized with CareDx, Inc. (formerly XDx, Inc.) the first joint AlloMap Symposium during the annual ISHLT (International Society for Heart and Lung Transplantation) Conference that was held from April 10 to April 13, 2014 in San Diego, CA.
AlloMap is CareDx's flagship gene-expression profiling based blood test which is exclusively licensed to Diaxonhit for Europe. 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 numerical score.
During this Symposium chaired by Ulrich Jorde, MD, Columbia University, NY and Paul Mohacsi, MD, University of Bern, Bern, Switzerland, several presentations were made by European and US practitioners:
- Unmet needs short term and long term after heart transplantation by Jorg Stypmann, MD, University of Münster, Münster, Germany;
- Heart transplant surveillance best practices by Sean Pinney, MD, Mount Sinai, NY ;
- HLA and AlloMap in cardiac immunity by Pr. Dominique Charron, MD, and Caroline Suberbielle, MD, Saint-Louis Hospital, Paris, France;
- AlloMap, the US experience in daily practice by Shelley Hall, MD, Baylor College of Medicine, Houston, TX.
In parallel, four clinical abstracts (1) highlighting the clinical utility of AlloMap were delivered during the scientific sessions at the ISHLT conference, showing increased use of AlloMap in the United States as a clinical tool for surveillance of heart transplant recipients:
- Comparative Utility of AlloMap Score Variability, Endomyocardial Biopsy, and Echocardiography to Predict Future Clinical Events in Heart Transplant Recipients, a poster by Mario Deng, MD, David Geffen School of Medicine, UCLA, Los Angeles, CA;
- Performance of Gene Expression Profiling Variability in Discriminating Heart Transplant Patients at Risk for Future Clinical Events, a poster by Jorg Stypmann, MD, University of Münster, Münster, Germany;
- Gene Expression Profile Score Variability Characteristics: Analysis of 49,836 Tests from 12,177 Heart Transplant Patients, by Andrew Kao, MD, St Luke's Mid America Heart Institute, Kansas City, MO;
- Gene Expression Profiling Test (GEP) Scores and Outcomes of Heart Transplant with Prior Mechanical Circulatory Support, by Nir Uriel, MD, University of Chicago, Chicago, IL.
"This first Symposium jointly organized by Diaxonhit and CareDx was an opportunity to confirm the growing use of AlloMap in the United States, as much in daily practice as in research of new biomarkers for the surveillance of heart transplant patients. In the year of AlloMap's European launch, this growing interest is quite encouraging, especially when shared with European practitioners " stated Loïc Maurel, MD, President of Diaxonhit's Management Board.
(1) These studies describe uses of AlloMap that are currently under investigation and are not yet cleared by the FDA as safe and effective. The FDA's AlloMap Decision Summary is available at www.accessdata.fda.gov/cdrh_docs/reviews/k073482.pdf.
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 CareDx 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 for 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.
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: transplantation, immuno-infection 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: www.diaxonhit.com
CareDx, 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 Gene Expression Testing, which aids physicians in determining the risk of acute cellular rejection in stable post-cardiac transplant patients. Some of the AlloMap technology developed by CareDx may be applicable to other conditions that involve transplant rejection and diseases that affect the immune system.
For more information, please visit: www.caredxinc.com.
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, Diaxonhit, 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. If the meaning of both texts differs, the French language version shall prevail.
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