Singulex, An Immunodiagnostics Company at the Forefront of Single Molecule Counting Technology

Singulex, an immunodiagnostics company at the forefront of Single Molecule Counting technology, a novel immunoassay technology recognized for unprecedented ultrasensitivity in the precision measurement of biomarkers, today announced that the company will present three posters, including one in collaboration with Stanford University, related to its investigational Singulex Clarity C. diff toxins A/B assay at the European Congress of Clinical Microbiology and Infectious Diseases.

Findings demonstrate the ultrasensitive Singulex Clarity C. diff toxins A/B assay, for use on the Singulex Clarity system, offers rapid results and a high level of sensitivity and specificity for the detection of Clostridium difficile toxins A and B in stool compared with currently available testing options. The Singulex Clarity system is a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology. With up to 1000 times higher sensitivity than existing technologies, Single Molecule Counting reveals the presence or absence of disease more clearly and definitively than possible before.

“Commercially available tests used to diagnose C. difficile infection lack either in sensitivity or specificity,” said Niaz Banaei, Associate Professor of Pathology and Medicine (Infectious Diseases) at the Stanford University Medical Center and primary investigator of one study (poster #2881). “Data show that this new, rapid, standalone immunoassay addresses these shortcomings by detecting nearly all cell cytotoxicity neutralization assay (CCNA)-positive samples. The Singulex assay offers clinicians a new tool for accurate diagnosis of C. difficile infection.”

The Singulex Clarity C. diff toxins A/B assay, powered by Single Molecule Counting, aims to be the first ultrasensitive test to offer physicians and laboratorians the specificity intrinsic to toxin tests but at a sensitivity level that rivals molecular methods.

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