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Singulex Applies CE Mark to Troponin Assay on Sgx Clarity System

NEW YORK (360Dx) – Singulex announced today that it has applied the CE mark to its ultra-sensitive troponin I assay, the Sgx Clarity cTnl Assay.

The assay quantitatively measures the biomarker troponin at far lower levels than existing technologies, and is indicated for use on the single molecule counting-based Sgx Clarity platform for in vitro diagnostics, the company said. The assay is meant to be used in conjunction with clinical evaluation for ruling out cardiac ischemia in patients suspected of having coronary artery disease.

"The increased sensitivity and analytical precision of this troponin I assay has the potential to greatly improve the safety and efficiency of myocardial ischemia rule-out in patients especially those presenting to the emergency department with chest pain," Alessandro Sionis, director of the acute and intensive cardiac care unit at the Hospital de la Santa Creu i Sant Pau in Barcelona, said in a statement.

Singulex CEO Guido Baechler added that the firm is working with European clinical research sites to develop best practices and training for optimal use of the test "for cardiac ischemia rule-out in patients suspected of having coronary artery disease."