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Singulex Announces CE Mark for Sgx Clarity® System

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Singulex has received CE marking for the Sgx Clarity® system, a fully-automated, in vitro diagnostics (IVD) platform, powered by Single Molecule Counting technology. Up to 1,000 times more sensitive than existing technologies, Single Molecule Counting technology measures biomarkers at the lowest levels, revealing what could not be seen before: the presence — or absence — of disease, so clinicians can provide the right treatment at the right time, resulting in better outcomes and cost savings.

“Leading cardiologists, laboratorians, and health providers know that Singulex’s Single Molecule Counting technology has advanced our knowledge of cardiac troponin and its ability to effectively understand heart health and status,” said Dr. Paul Collinson, Professor of Cardiovascular Biomarkers at St. George's University of London. “By applying the power and sensitivity into an easy-to-use IVD platform via the Sgx Clarity system, we can now put that technology to use and make better informed treatment decisions, improve care management, and help lower cost.”

Single Molecule Counting technology has been reported on in more than 130 peer-reviewed publications. Further clinical evaluation at sites in Barcelona, London, and Manchester is confirming the sensitivity and utility of this IVD system, which is designed to seamlessly integrate into laboratory workflow. 

“This is a momentous day for Singulex. We are pleased to achieve CE mark and begin the sale of our Sgx Clarity system in Europe,” said Guido Baechler, president and chief executive officer of Singulex. “Our vision is to revolutionize immunodiagnostics to guide treatment decisions and improve healthcare systems across the globe. We continue to develop assays to detect and rule out highly preventable diseases, such as cardiac, infectious, and inflammatory diseases. Together with our extensive physician and laboratorian network in Europe, we are now active in driving access and adoption of the Sgx Clarity system across the continent.”

Singulex plans to CE mark a cardiac troponin I (cTnI) assay in Europe and will submit data for regulatory clearance of the Sgx Clarity system in the United States, anticipating U.S. Food and Drug Administration clearance in 2018. With a long-term vision for innovation in the field of advanced immunodiagnostics, Singulex is also developing a point-of-care platform for its Single Molecule Counting technology and is exploring additional applications beyond the clinical setting.