Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

XDx Launches AlloMap® Molecular Expression Testing in Germany

Published: Thursday, April 05, 2012
Last Updated: Thursday, April 05, 2012
Bookmark and Share
Non-invasive blood test helps physicians monitor risk of acute cellular rejection in stable heart transplant recipients.

XDx, Inc. announced the launch of AlloMap® Molecular Expression Testing in Germany. AlloMap is XDx’s easy and convenient, non-invasive blood test that aids physicians in determining a stable heart transplant patient’s risk of acute cellular rejection without requiring the use of endomyocardial biopsy. Heart transplant specialists initiated use of AlloMap in selected German hospitals in March 2012, and XDx expects to make AlloMap available to additional German, Swiss and Austrian transplant centers throughout the second quarter of this year in the first stage of a broader European launch.

In the United States, AlloMap is FDA-cleared and has been on the market since 2005. In 2010, a study called Invasive Monitoring Attenuation Through Gene Expression (IMAGE) demonstrated that AlloMap was non-inferior to biopsy with respect to clinical outcomes, including survival and absence of graft dysfunction. In addition, the study showed a reduction in the use of biopsies by 75% on average. Patients also gave a higher satisfaction rating to AlloMap than biopsy for the method used for detecting rejection. Based on these results, AlloMap testing is recommended in the practice guidelines of the International Society for Heart and Lung Transplantation (ISHLT).

In April 2011, AlloMap received a CE mark in the European Union under the In Vitro Diagnostics Directive. Findings from a European study (CARGO II) of AlloMap will be presented at the ISHLT’s 32nd Annual Meeting & Scientific Sessions being held April 18-21, 2012 in Prague, Czech Republic. CARGO II was designed to further validate results from the landmark multi-center, prospective, validation study known as the Cardiac Allograft Rejection Gene Expression Observational (CARGO) study completed by XDx in the US.

Pierre Cassigneul, President and CEO of XDx, said, “We are excited to initiate the European AlloMap launch in Germany, which represents the largest heart transplant market in the EU, which overall is similar in size to the US market. Closely following the launch in Germany, we will soon begin making AlloMap available in Switzerland and Austria. By next year, we anticipate expanding our reach to additional large European markets.”

Jörg Stypmann, M.D., PhD, transplant cardiologist in the Department of Cardiology and Angiology of the University Hospital Münster, Germany, commented, “Heart transplant recipients must be regularly monitored for acute cellular rejection, and currently in our institution they undergo up to 15 invasive, protocol biopsy procedures in their lifetime. There is a great clinical need to determine a patient’s individual risk of rejection in order to spare them so many uncomfortable procedures, which also involve moderate risk of adverse events. We think that AlloMap, a non-invasive test with its high negative predictive value, can provide a much-needed alternative strategy to monitor effectiveness of immunosuppressive therapy during the first year after heart transplantation and in the longer term. AlloMap also can potentially reduce the number of right ventricular biopsies in stable patients.”


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
Heart Arrhythmia Caused by Mosaic of Mutant Cells
Researchers have solved the genetic mystery of an infant suffering from heart arrhythmia.
Crispr Toolbox Expanded By Protein
Researchers have shown a newly discovered CRISPR protein has two distinct RNA cutting activities.
Over Two-Thirds of Cervical Cancer Deaths Prevented
Cervical screening prevents 70% of cervical cancer deaths and if all eligible women regularly attended screening this would rise to 83%.
Detecting Bacterial Infections in Newborns
Researchers tested an alternative way to diagnose bacterial infections in infants—by analyzing RNA biosignatures from a small blood sample.
Mechanisms of Parkinson’s Pathology
Defects that lead to cells’ failure to decommission faulty mitochondria cause nerve cells to die, triggering the symptoms of Parkinson’s disease.
Case for Liquid Biopsies Builds in Advanced Lung Cancer
Study addresses unmet need for better, non-invasive tests called out in recent "Moonshot" blue ribbon panel report
Genetic Misdiagnoses of Heart Condition
Analysis found several genetic variations previously linked with a heart condition were harmless, leading to condition misdiagnosis.
Opening Door to Oesophageal Cancer Targeted Treatments
Scientists have discovered that oesophageal cancer can be classified into three different subtypes.
Genetic Diversity of Enzymes Alters Metabolic Individuality
ToMMo scientists have shown that genetic polymorphisms, structural location of mutation and effect for phenotype correlate with each other.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!