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Singulex actively collaborated with cardiologists to understand the clinical value of measuring cardiac troponin at previously immeasurable levels in blood

Singulex today announced it has filed a 510(k) pre-market notification submission with the FDA for its Singulex Clarity cTnI assay to run on the Singulex Clarity system.

Measurement of cardiac troponin in stable patients with chest pain using the ultra-sensitive Singulex cTnI assay and Single Molecule Counting technology can independently predict moderate and severe coronary disease (CAD), suggesting its clinical utility for accurate, safe and cost-effective evaluation of patients in an outpatient setting, according to a study appearing in the March issue of the Journal of the American College of Cardiology Imaging.