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.”
Measuring Neutrophil Motility Could Lead to Accurate Sepsis DiagnosisNews
Mass. General researchers design device that rapidly diagnoses sepsis with more than 95 percent accuracy.READ MORE
New Blood Test Could Help Distinguish Heart Attack from Heart StrainNews
A new blood test developed by a UAlberta medical researcher is better at detecting damage to the heart caused by an actual heart attack. The test promises to improve how physicians diagnose and treat patients experiencing a possible heart attack.READ MORE
Rapid Test Helps with Administering the "Correct" DrugNews
In just three hours, a new rapid test will give information on which available antibiotic is still effective in a concrete case.READ MORE
Comments | 0 ADD COMMENT
World Congress on Advanced Pharmacy and Clinical Research
Jul 16 - Jul 17, 2018
World Congress on Pathology and Laboratory Medicine
Sep 10 - Sep 11, 2018
World Congress on Advances in Addiction Science and Medicine
Sep 24 - Sep 25, 2018