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Abacus Diagnostica Receives CE Mark for its Rapid Direct PCR Test for Toxigenic Clostridium Difficile
Date:11/19/2012

ar we will continue to expand our molecular test offering for critical blood stream and perinatal infections."

About the GenomEra CDX™ System Molecular Diagnostic Platform

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 ISO9001:2008 and ISO13485:2003 certified IVD company specialized in rapid DNA testing. Our 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
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SOURCE Abacus Diagnostica Ltd
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