Genetic Signatures receives CE mark for EasyScreen™ C. difficile Detection Assay

Genetic Signatures is pleased to announce that it has gained the European CE-IVD Mark for its EasyScreen™ C. difficile Detection Kit. The real-time multiplex PCR assay can be used directly from patient stool samples and yields a result in approximately 3 hours. The CE-IVD approval paves the way for CE-IVD marking of the EasyScreen™ C. difficile Reflex Kit, expected in the coming weeks. The EasyScreen™ C. difficile kits detect the more dangerous hypervirulent forms of C. difficile such as ribotype 027 and 078. Ribotype 027 has been responsible for numerous outbreaks worldwide and is associated with a more virulent form of the disease.