Singulex Clarity® C. diff toxins A/B assay in development shown to be ultrasensitive and highly specific compared with currently available testing options

Findings presented in three posters at the European Congress of Clinical Microbiology and Infectious Diseases

MADRID, (April 24, 2018) – 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. 

The three posters will be on view April 24th from 12:30-1:30pm with representatives from Singulex and Stanford University available to answer questions. 

Abstract Poster #P2281

Title: Clinical evaluation of the Singulex Clarity C. diff toxins A/B assay, currently in development, for ultrasensitive detection of Clostridium difficile toxins A and B

Summary: In a study together with Dr. Niaz Banaei at Stanford University Medical Center, it was shown that the Singulex Clarity C. diff toxins A/B assay yielded 98% sensitivity and 100% specificity compared to multistep PCR-and-toxin testing. It was concluded that the assay is ultrasensitive and highly specific and may offer a standalone solution for the rapid detection and quantitation of free toxins in stool.

Abstract Poster #P2282

Title: Evaluation of the Singulex Clarity C. diff toxins A/B assay, currently in development, for ultrasensitive detection of Clostridium difficile toxins

Summary: In a study evaluating the analytical performance of the Singulex Clarity C. diff toxins A/B assay, it was shown that the assay can detect C. difficile toxins at concentrations lower than commercially available toxin assays and that it had high sensitivity and specificity compared to CCNA. The Singulex Clarity C. diff toxins A/B assay demonstrated reactivity to common C. difficile strains, did not show cross-reactivity to common gastrointestinal pathogens, was robust against common interferents at relevant concentrations, allowed for detection of toxins in both fresh and frozen stool samples and up to three freeze-thaw cycles, and provided results with high reproducibility.

Abstract Poster #P2283

Title: Preliminary performance evaluation of an automated Singulex Clarity C. diff toxins A/B assay and comparison to PCR and multi-step algorithms

Summary: The clinical performance of the Singulex Clarity C. diff toxins A/B assay compared to CCNA and relative to current C. difficile testing options was determined in a study together with TriCore Reference Laboratories in Albuquerque, New Mexico, USA. When assessing sensitivity and specificity compared to CCNA, the Singulex Clarity C. diff toxins A/B assay outperformed PCR, EIA, and two multistep algorithms.

The Singulex proprietary Single Molecule Counting technology has been validated in clinical studies involving more than 140,000 subjects, resulting in over 180 peer-reviewed publications. The company anticipates registration of the C. difficile toxins A/B assay for use with the Singulex Clarity system to the US Food and Drug Administration before the end of 2018.

About C. difficile infection
C. difficile infection is the leading cause of gastroenteritis-associated death and has become the most common cause of health care–associated infections in U.S. hospitals. The excess health care costs related to C. difficile infection are estimated to be as much as $4.8 billion for acute-care facilities alone. 

About Singulex 

Singulex is 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. Singulex is the developer of the Singulex Clarity system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology. In 2017, Singulex filed a 510(k)-pre-market notification submission with the U.S. Food and Drug Administration. The Singulex Clarity system and Singulex Clarity cTnI assay have the CE mark and are commercially available in Europe. Additional assays to detect and rule out infectious and inflammatory diseases are in development. Singulex is also developing a point-of-care platform and exploring applications beyond the clinical setting. For more information, please visit www.singulex.com or singulexclarity.eu.