Ultra-sensitive cardiac troponin test using Single Molecule Counting technology receives CE mark

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Singulex has been granted CE mark for its ultra-sensitive troponin assay (cTnl), the first offered by the company’s Sgx Clarity system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology.

Sgx Clarity cTnl Assay is designed to quantitatively measure the biomarker troponin at levels far lower than existing technologies. The Sgx Clarity cTnl Assay is indicated to be used in conjunction with clinical evaluation for ruling out cardiac ischaemia in patients suspected of having coronary artery disease. Efficient rule-out helps avoid the costs and adverse effects of additional expensive and potential unnecessary testing, such as stress tests, and allows clinicians to focus resources on the sickest patients.

“This is a tremendously attractive concept, especially, from an urgent care perspective,” says Alessandro Sionis, director of the Acute and Intensive Cardiac Care Unit, Hospital de la Santa Creu i Sant Pau, Universitat de Barcelona, Barcelona, Spain. “The increased sensitivity and analytical precision of this troponin I assay has the potential to greatly improve the safety and efficiency of myocardial ischaemia rule-out in patients, especially those presenting to the emergency department with chest pain.”

Up to 100 times more sensitive than existing technologies, a company release states, Single Molecule Counting-based diagnostics are the first ultra-sensitive tests to routinely and effectively identify minute quantities of biomarker molecules, giving clinicians greater insight, confidence and certainty in disease detection, rule-out and management.

The Singulex proprietary Single Molecule Counting technology has been validated in clinical studies involving more than 130,000 subjects, resulting in over 130 peer-reviewed publications, according to the release. The company will submit data for regulatory clearance of the Sgx Clarity system and the Sgx Clarity cTnI Assay in the USA, anticipating US Food and Drug Administration clearance in 2018.

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