Ganymed Pharmaceuticals Announces CE Marking for Solid Tumour Test
News Sep 11, 2013
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.”