Abacus Diagnostica Receives CE Mark for its Rapid Direct PCR Test for Toxigenic Clostridium Difficile
Abacus Diagnostica Ltd has announced 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. C. difficile is the leading cause of infectious nosocomial diarrhea in Europe and North America.
Rapid changes in the epidemiology and increasing incidence have taken the focus on methods to diagnose toxigenic C. difficile faster and more efficiently. Accurate and rapid diagnosis of C. difficile infection is crucial for patient care but also for preventing transmission and reducing the overall disease burden.
The GenomEra C. difficile assay is the newest test of Abacus Diagnostica's expanding line of easy-to-use and cost-efficient molecular diagnostics products. The C. difficile test is extremely simple to perform directly from stool specimen through a straightforward sample preparation process without extraction, heating or centrifugation steps. The assay is built on rapid and reliable target amplification and end-point detection technology that allows for high quality results in 50 minutes.
- Abacus is committed to providing a continuum of diagnostic products for key infectious diseases to meet the needs of various laboratory settings, said Tom Palenius, CEO of Abacus Diagnostica.
- Along with our earlier CE marked MRSA/SA assays this PCR test will help to meet the testing and resource challenges of many different types of labs. During next year we will continue to expand our molecular test offering for critical blood stream and perinatal infections.
The GenomEra CDX system is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GenomEra CDX system is designed for clinical routine use for identification of target nucleic acid sequences directly from crude clinical samples and delivering reliable non-confusing answers in less than in one hour.
The GenomEra CDX system combines minimal sample preparation with rapid and high-performing PCR (polymerase chain reaction) amplification and end-point detection for fully integrated and automated nucleic acid analysis. GenomEra CDX system is the first commercial homogenous PCR platform to use thermally stable, intrinsically fluorescent time-resolved fluorometric (TRF) labels combined with a proprietary assay and measurement technology with effective elimination of background effects originating from e.g. crude clinical samples.
About Abacus Diagnostica
Abacus Diagnostica Oy is a Finnish IVD company specialized in rapid DNA testing. Company’s proprietary, fully automated GenomEra CDX™-platform makes it possible to perform high-performance DNA-based testing even outside a specialized laboratory and by personnel without experience in molecular biology.
The company's business focus is in Healthcare Associated Infections, Bloodstream Infections and Perinatal Diagnostics. The Abacus GenomEra CDX system is currently available in Europe with CE-IVD mark. Applications include a test panel for MRSA/SA for various matrixes including blood culture for sepsis care, and the Clostridium difficile test for stool samples. Next tests in pipeline are Streptococcus pneumoniae and Streptococcus agalactiae (GBS).