Abacus Diagnostica said recently that it has received the CE mark for the GenomEra C. difficile assay for the detection of toxin-producing Clostridium difficile directly from stool samples.
The GenomEra C. difficile assay is extremely simple to perform directly from stool specimen through a straightforward sample preparation process without extraction, heating or centrifugation steps, Abacus said. The assay is built on rapid and reliable target amplification and end-point detection technology that produces high-quality results in 50 minutes.
The assay runs on the GenomEra CDX system, a closed, self-contained, fully integrated and automated testing platform designed for clinical routine use. The platform combines minimal sample preparation with rapid PCR amplification and end-point detection. It is the first commercial homogenous PCR platform to use thermally stable, intrinsically fluorescent time-resolved fluorometric labels combined with a proprietary assay and measurement technology to eliminate background effects originating from, for example, clinical samples, the company said.