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

Ganymed Pharmaceuticals Announces CE Marking for Solid Tumour Test

Published: Wednesday, September 11, 2013
Last Updated: Wednesday, September 11, 2013
Bookmark and Share
CLAUDETECT™18.2 is the first and only CE marked IVD test specific for the detection of Claudin-18.2 in gastroesophageal, pancreatic and other solid tumors.

Ganymed Pharmaceuticals has announced that it has fully developed and obtained CE marking for its in vitro diagnostic (IVD) test CLAUDETECT™18.2 which allows to assess the expression levels of Claudin-18.2 (CLDN18.2) in solid tumors.

CLAUDETECT™18.2, which was developed in collaboration with Theracode GmbH, is now compliant with the requirements of European Community Directive 98/79/EC on in vitro diagnostic medical devices.

CLAUDETECT™18.2 is a semi-quantitative immunohistochemical assay that determines selectively CLDN18.2 protein expression in formalin fixed paraffin-embedded cancer tissue in particular from patients with adenocarcinoma of the stomach, esophagus and pancreas as well as bile duct and lung.

CLDN18.2 is the target of the therapeutic antibody IMAB362, Ganymed’s lead investigational drug product. IMAB362 is being developed for first-line treatment of gastroesophageal adenocarcinomas.

CLAUDETECT™18.2 is being used in all ongoing clinical studies to determine the condition of use for IMAB362. This includes a randomized Phase IIb trial, which compares IMAB362 in combination with best standard treatment to best standard treatment alone.

“Ganymed is dedicated to develop predictive biomarkers that complement new therapeutic concepts in cancer treatment and hold promise for personalizing medicine” said Dr Özlem Türeci, CEO of Ganymed Pharmaceuticals.

Dr Türeci continued, “With the CE marking of CLAUDETECT™18.2, we have achieved an important milestone in the concurrent development of our drug IMAB362 and the diagnostic tool intended to aid in the identification of patients for treatment with IMAB362.”


Further Information
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 2,500+ scientific posters on ePosters
  • More than 3,700+ 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
The Changing Tides of the In Vitro Diagnostics Market
With the increasing focus in personalized medicine, diagnostics plays a crucial role in patient monitoring.
Poor Survival Rates in Leukemia Linked to Persistent Genetic Mutations
For patients with an often-deadly form of leukemia, new research suggests that lingering cancer-related mutations – detected after initial treatment with chemotherapy – are associated with an increased risk of relapse and poor survival.
'Fountain of Youth' Protein Points to Possible Human Health Benefit
Patients with higher blood levels of growth factor have lower risk of cardiovascular problems.
Signature of Microbiomes Linked to Schizophrenia
Studying microbiomes in throat may help identify causes and treatments of brain disorder.
Imaging Software Could Speed Breast Cancer Diagnosis
Technology could improve access to diagnostic services in developing countries.
Data Mining DNA For Polycystic Ovary Syndrome Genes
A new Northwestern Medicine genome-wide association study of PCOS – the first of its kind to focus on women of European ancestry – has provided important new insights into the underlying biology of the disorder.
Algorithm Interprets Breathing Difficulties to Aid in Medical Care
Researchers from North Carolina State University have developed an efficient algorithm that can interpret the wheezing of patients with breathing difficulties to give medical providers information about what’s happening in the lungs.
Researchers Develop qPCR Prognosis Test for NSCLC Patients
A nine-gene molecular prognostic index (MPI) for patients with early-stage non-small cell lung cancer (NSCLC) was able to provide accurate survival stratification and could potentially inform the use of adjuvant therapy in patients struggling with the disease.
Genetic Test Could Improve Blood Cancer Treatment
Testing for genetic risk factors could improve treatment for myeloma – a cancer of the blood and bone marrow – by helping doctors identify patients at risk of developing more aggressive disease.
PTR-MS Breath Test Shows Potential for Detecting Liver Disease
Researchers at the University of Birmingham have published results that suggest a non-invasive breath test for liver disease using an IONICON PTR-MS.
Skyscraper Banner

Skyscraper Banner
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
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!