Genetic Signatures receives CE mark for EasyScreen™ C. difficile Reflex Assay
Genetic Signatures is pleased to announce that it has gained the European CE-IVD Mark for its EasyScreen™ C. difficile Reflex Kit. The real-time multiplex PCR assay can be used directly from patient stool samples and yields a result in approximately 3 hours. The EasyScreen™ C. difficile Reflex kit detects the more dangerous hypervirulent forms of C. difficile (such as ribotype 027 and 078) via presence of the following genetic markers 1) the tcdC gene deletion at position 117, 2) the binary toxin (cdtA) gene and 3) the gyrA mutation, responsible for fluroquinolone resistance. Ribotype 027 has been responsible for numerous outbreaks worldwide and is associated with a more virulent form of the disease. This approval follows the CE-IVD marking of the EasyScreen™ C. difficile Detection Kit for the simultaneous detection of both tcdA and tcdB genes.