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Singulex Receives CE Mark for Sgx Clarity System

NEW YORK (GenomeWeb) – Singulex said today that it has received the CE mark in Europe for its Sgx Clarity system. The Alameda, California-based immunodiagnostics firm will now start marketing its single-molecule counting instrument as an in vitro diagnostics system.

Singulex also plans to pursue the CE mark for its cardiac troponin I assay and plans to submit data to the US Food and Drug Administration for clearance in 2018.

"We continue to develop assays to detect and rule out highly preventable diseases, such as cardiac, infectious, and inflammatory diseases," Singulex CEO Guido Baechler said in a statement. "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."

"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," Paul Collinson, professor of cardiovascular biomarkers at St. George's University of London, said in a statement. "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."

Last month, the company said that it had expanded clinical testing of its system at four European clinical research sites in order to evaluate its utility in cardiac care. And earlier this year, the company said it was developing a point-of-care instrument and planned to have a prototype by the end of the year.