Immunodiagnostics company Singulex said on Wednesday that it has submitted its 510(k) pre-market notification submission with the US Food and Drug Administration for its Singulex Clarity cTnI assay on the fully-automated Singulex Clarity system to reveal the presence or absence of cardiac, infectious and inflammatory disease.

The company said the Singulex Clarity cTnI assay runs on the Singulex Clarity system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology. The Singulex Clarity cTnl assay is the first test to quantitatively measure cardiac troponin at levels far lower than existing technologies. The indication submitted for review is for use in conjunction with clinical evaluation as an aid in the diagnosis of myocardial infarction.

Up to 1,000 times more sensitive than existing technologies, the company's new Single Molecule Counting-based diagnostics are the first ultra-sensitive tests to routinely identify minute quantities of biomarker molecules, giving clinicians greater insight, confidence and certainty in earlier detection, rule-out and management of disease.

According to the company, the Singulex proprietary Single Molecule Counting technology has been validated in clinical studies involving more than 130,000 subjects, resulting in over 150 peer-reviewed publications.

In conjunction, the company has CE marked the Singulex Clarity system and the Singulex Clarity cTnl assay to be used in conjunction with clinical evaluation for ruling out cardiac ischemia in patients suspected of having coronary artery disease (CAD) clearing the path for the commercialisation of the assay and instrument in the EU.