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Singulex's Troponin Assay Gets CE Marking

NEW YORK (GenomeWeb) – Singulex on Thursday said that it has received CE marking for its Sgx Clarity cTnl assay for the quantitative measurement of troponin.

The test is the first offered for the Sgx Clarity system, a fully automated in vitro diagnostic platform leveraging single-molecule counting technology, and measures troponin at levels "far lower than existing technologies," according to Singulex. The assay is indicated for use in conjunction with clinical evaluation for ruling out cardiac ischemia in patients suspected of having coronary artery disease.

Singulex President and CEO Guido Baechler said that the firm is working closely with European researcher sites "to develop best practices and training for optimal introduction and utility" for the test.

Singulex received CE marking for the Sgx Clarity system in April. It said that it will submit data for clearance by the US Food and Drug Administration for the system and the troponin assay, and anticipates receiving clearance in 2018.