Solid Tumor Marker Diagnostic Test Receives CE Certification
27 Sep 2013
A CE-certified in vitro diagnostic test is now available for the semi-quantitative determination of the tumor marker Claudin-18.2 (CLDN18.2).
The test called CLAUDETECT 18.2, was developed jointly by Ganymed Pharmaceuticals (Mainz, Germany) and Theracode GmbH (Mainz, Germany), and will be marketed by Ganymed.
Ganymed Pharmaceuticals AG is a biopharmaceutical company that has developed a new class of therapeutic drugs called Ideal Monoclonal Antibodies (IMABs). IMABs are unique in that they are highly selective for proteins present on tumor cells, but do not bind to healthy cells. Theracode GmbH is an in vitro diagnostics company that combines its in-house scientific and management expertise in immunology, molecular pathology, and clinical medicine with its own integrated discovery and development platform to identify, validate, develop, manufacture, and market in vitro diagnostic kits based upon new classes of highly sensitive and cancer specific molecular markers.
CLAUDETECT 18.2 is a semi-quantitative immunohistochemical assay that determines selectively CLDN18.2 protein expression in formalin fixed paraffin-embedded (FFPE) cancer tissues. The tight junction protein Claudin-18.2 is expressed in up to 80% of gastroesophageal adenocarcinomas, 60% of pancreatic tumors as well as in other various solid tumors. CLDN18.2 is the target of the therapeutic antibody IMAB362, Ganymed’s lead investigational drug product.
The CLAUDETECT 18.2 test has been certified to comply with the requirements of European Community Directive 98/79/EC on in vitro diagnostic medical devices for use in diagnosing patients with adenocarcinoma of the stomach, esophagus, and pancreas as well as bile duct and lung.
“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. “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.”