NEWS RELEASE
CareDx Announces the First Commercial European AlloMap
Test Reported from its Reference Lab
Company and its European Partner, Diaxonhit, advance AlloMap global footprint with first result reported to Munich, Germany
Brisbane, CA and Paris, France July 1, 2014, CareDx, Inc., a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value, non-invasive surveillance solutions for transplant recipients and Diaxonhit, the leading French provider of specialty diagnostic solutions, today announced that CareDx has successfully tested its first European AlloMap commercial sample, which was shipped directly from Transplantationszentrum München, a leading transplant hospital in Munich, Germany, to the clinical laboratory at CareDx in Brisbane.
Through its European commercial partner, Diaxonhit, CareDx has established an exclusive distribution channel for AlloMap in the European Union. This reported test represents the first commercial result rendered in Europe. CareDx and Diaxonhit are currently working on plans for the AlloMap test to be performed directly in Europe through an exclusively licensed laboratory.
"AlloMap - our non-invasive blood test service - provides a non-invasive solution for heart transplant surveillance to clinicians and patients," said Peter Maag, President and CEO of CareDx, Inc. "I am very proud that we have the processes and procedures in place to receive samples and report results outside the United States, as demonstrated with this sample from Germany, and that we generated our first commercial result in the first half of 2014."
"A milestone was reached as European heart transplant patients can now also benefit from Allomap, an advanced, molecular and non-invasive blood-test. Diaxonhit shares CareDx's pride with this first commercial test performed in California for a German patient. While we are in the process of finalizing the set-up of a central laboratory in Europe, our teams worked closely together to accelerate commercialization of Allomap," said Loïc Maurel, MD, President of the Management Board of Diaxonhit.
_____________
About AlloMap®
AlloMap Molecular Testing is intended to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (ACR) at the time of testing in conjunction with standard clinical assessment. AlloMap is performed in the CLIA-certified and CAP-accredited clinical laboratory at CareDx 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. Recommended use of AlloMap for heart transplant rejection surveillance is included in the International Society for Heart and Lung Transplantation (ISHLT) Guidelines for the care of heart transplant recipients, published in August, 2010: "Gene Expression Profiling (Allomap) can be used to rule out the presence of ACR of grade 2R or greater in appropriate low-risk patients, between 6 months and 5 years after HT." These guidelines represent the worldwide standard for the care of heart transplant patients.
About CareDx
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 diagnostic surveillance solutions for transplant recipients. The company has commercialized AlloMap, a gene expression test that aids clinicians in identifying heart transplant recipients with stable graft function.
For more information, please visit: www.CareDxInc.com.
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: 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
Contacts
CareDx, Inc.
Bradley P. Sherrill
Senior Director, Marketing
Tel: 415-287-2397
bsherrill@CareDxInc.com
Diaxonhit
Hervé Duchesne de Lamotte
Chief Financial Officer
Tel: +33 1 53 94 52 49
herve.delamotte@diaxonhit.com
ACTIFIN
Financial Communication
Tel: + 33 1 56 88 11 11
Investors Relations
Alexandre Commerot
acommerot@actifin.fr
Press Relations
Jennifer Jullia
jjullia@actifin.fr
