OREANDA-NEWS. May 26, 2016. DIAXONHIT (Alternext: ALEHT, FR0004054427), the leading French provider of specialty in-vitro diagnostic solutions for transplantation, infectious diseases and oncology, and the University Hospitals of Strasbourg (HUS) inaugurate today a center dedicated to AlloMap® testing, a new molecular blood test developed by the U.S. company CareDx Inc. for the periodic and noninvasive monitoring of acute cellular rejection in heart transplant patients.

DIAXONHIT, which owns the exclusive license rights to AlloMap® in Europe, signed a service agreement with the HUS for conducting the tests. Under the terms of this agreement, all tests will be processed in the HUS's Central Immunology Laboratory, under the exclusive supervision and responsibility of the HUS and the Laboratory's Scientific Director, Professor Seiamak Bahram, with the support of Doctors Mirjana Radosavljevic ("AlloMap team leader") and Raphael Carapito.

"Our collaboration with the University Hospitals of Strasbourg, including the Immunology Laboratory of Professor Bahram, is unprecedented in Europe. Indeed, a French research center will perform AlloMap molecular testing for heart transplant patients being monitored all over Europe. AlloMap provides a noninvasive, innovative solution to monitor heart transplant patients. AlloMap is already approved in the U.S. and Europe and has been successfully tested on a large population of patients in those regions, including in France. To date, more than 50% of American heart transplant patients have already benefited from AlloMap. We are delighted that the patients of French and European heart transplantation centers will now be able to benefit from AlloMap as well, a test that has been routinely used in the US for many years," said Lo?c Maurel, President of the Management Board of DIAXONHIT.

"We are extremely pleased to have been selected as the exclusive European site where AlloMap® tests will be conducted, which highlights the unique position of our laboratory, at the crossroad of medical research and its applications," added Professor Bahram Seiamak, Scientific Director of the Central Immunology Laboratory of the University Hospitals of Strasbourg.

AlloMap®, the only noninvasive blood test available on the market for the monitoring of heart transplant patients

AlloMap® is the only blood test available on the market offering health professionals and patients a noninvasive solution to monitor heart transplants and the risks of rejection, which are especially high during the first year.

"This noninvasive test is scientifically and intellectually sound, and represents a major advance in the field of transplantation," said Dr. Shaida Varnous, a cardiologist and the Head of the Heart Transplant Program at the Piti? Salp?tri?re Hospital, in Paris.

Currently, heart transplant patients are monitored via myocardial biopsy, a surgical procedure that has to be performed once a week during the first month following the surgery and 10 to 15 times afterward throughout the first year. Due to the invasive and constraining nature of this procedure, hospitals tend to decrease the frequency of biopsies after that first year, or stop them entirely, which prevents from optimally monitoring heart transplant patients.

To reduce the risks associated with biopsies and improve the monitoring of transplant patients, CareDx, Inc. has developed a new method for the periodic and noninvasive monitoring of acute cellular rejection in heart transplant patients. Blood samples taken from patients in heart transplant centers across Europe are now being shipped to the laboratory in Strasbourg, where AlloMap® tests are performed. After analyzing the samples, the laboratory sends back the results within a few days directly to the center's cardiologists and heart surgeons.

"The benefits for patients are obvious. Although transplant patients are used to heart biopsy, and while it results in fewer complications when performed by trained personnel, it remains an invasive procedure. This new technique significantly improves patients' comfort: with the AlloMap test, instead of hospitalizing patients for an entire day, a simple blood sample is sufficient to monitor them," said Dr. Eric Epailly, a heart surgeon and Medical Director of the heart transplant and cardiopulmonary program at the University Hospitals of Strasbourg.

The University Hospitals of Strasbourg, at the forefront of medical innovation and in the heart of Europe

Selected by DIAXONHIT for its ability to properly handle the AlloMap® test procedure, the HUS's Central Immunology Laboratory meets all the quality and safety requirements to ensure the accuracy and reproducibility of the results provided to prescribers.

Under the direction of Professor Seiamak Bahram, who is also the head of TRANSPLANTEX, a "Laboratory of Excellence" (LabEx) at the forefront of innovation in transplantation and histocompatibility in Europe, a dedicated team of medical biologists, scientists and experienced technicians, led by Dr. Mirjana Radosavljevic, will carry out the AlloMap® test procedure in a well-defined environment and with specific instruments. The HUS's staff was also trained on the use of the AlloMap® test.

DIAXONHIT provides the Central Laboratory in Strasbourg with the test's components manufactured by CareDx as well as with the instruments required to perform the test. DIAXONHIT also provides the European heart transplant centers with a kit to take and ship the blood samples.

Ideally located in the heart of Europe in Strasbourg, this AlloMap Central European Laboratory allows to timely process the blood samples received from all over Europe and simplifies the logistics for the European heart transplant centers.

A medico-economic study starting in Q2 2016

A medico-economic study ('Programme de Recherche M?dico-Economique' - PRME) seeking to expand patients' insurance coverage to this test has been approved and is being funded by the French Ministry of health. It will be performed by an independent group of biologists and heart surgeons, under the supervision of the Hospices Civils of Lyon (HCL). This study will assess the benefits of the test, compared to the current method of monitoring heart transplant patients via myocardial biopsy. The study just started and the first 3 patients have already been enrolled.

"Once this study is finalized, we will know exactly what to expect in terms of spending for the benefit of our patients and medical teams. The health authorities will be able to make an informed decision about whether this test will be included in the health-insurance plan of patients or not. I really think that this test is critical to the practice of medicine today. It is a new technology that will revolutionize the lives of heart transplant patients," said Dr. Laurent Sebbag, a cardiologist at the Louis Pradel Heart and Pulmonary Hospital in Bron, France.

A sizeable market in Europe

In Europe, around 1,500 patients receive a heart transplant as a last resort every year, and approximately 20,000 people currently live with a transplanted heart. Five countries (France, Germany, Italy, Spain and the UK) account for 70% of these transplants, half of which are performed in 25 major hospitals, including the Center of Strasbourg.

About DIAXONHIT

DIAXONHIT (Alternext: FR0004054427, ALEHT) is a major player in in-vitro diagnostics. As such, the company is involved in the development and marketing of diagnostic tests in the fields of transplantation, infectious diseases and oncology, and is the French leader in HLA tests. With its various partnerships and strong hospital presence, DIAXONHIT has built an extensive distribution network and a large portfolio of products exclusively owned by the company, including Tetanus Quick Stick® and BJI Inoplex®, in the field of infectious diseases. Each year, the Group invests more than 15% of its revenues in R&D to keep developing new proprietary diagnostic tests. DIAXONHIT, based in Paris, has over 85 employees. The Group is listed on the indices Alternext BPI Innovation, PEA-PME 150 and Next Biotech indices.

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

Ticker: ALEHT - ISIN code: FR0004054427 -  Reuters: ALEHT.PA - Bloomberg: ALEHT:FP

About the University hospitals of Strasbourg

Ranked among the top French university hospitals, the University hospital of Strasbourg is renowned for the quality of the care provided, the excellence of its level of clinical research excellence and innovation, and its leadership in the initial or continuous training of the healthcare professionals in the Alsace region. The collaboration, which is internationally recognized in the Shanghai academic ranking, between the University Hospital of Strasbourg and the University of Strasbourg on various projects, stands as an example within the teaching hospital national landscape.

The hospital excellence

Thanks to its University Hospital Institute, Institute of Image-Guided Surgery, its 21 approved teams (CNRS, INSERM, University of Strasbourg) and its partnership on 4 LabEx (Excellence Laboratories), the research is at the core of the University hospital of Strasbourg's strategy. It contributes to the medical progress and provides the means to lead the most innovative projects to the benefit of the patients.

Leading various projects, including the Medico-Technical and Locomotor Platform unit, the Regional Institute of the Cancer, and the overseas and European development, the University Hospital of Strasbourg  pursues an ambitious policy, not only in favor of the Alsatian population and beyond, but also on renowned excellence disciplinary fields at national, European and international level : robotic surgery, artificial larynx,  implantation of an artificial retina, cryotherapy, allergology with the creation of the first allergenic room in France, transplants  (among  the  5 biggest French centers),  hand microsurgery, immunology, etc.

A high-performance full technical platform

With a wide range of care  supply, the University Hospital of Strasbourg has equipment at the cutting edge of medical and therapeutic innovation in order to carry out its diagnosis, care and research mission: PET-SCAN, 5 MRIs, one of which is an interventional one, 4 gamma cameras, 6 scanners, 4 assistance robots in video-laparoscopic surgery, neurosurgery and cardiovascular surgery.

www.chru-strasbourg.fr

Key figures 2014

About 1 billion euros of budget 13 000 healthcare professionals for the benefit of the patients
6 hospitals: 2 800 beds, places and stations
390 transplants
6 200 childbirths
2 850 publications in research (2009-2012)
7 training schools and institutes preparing 1 300 students per year