FDAnews Device Daily Bulletin

Cardiac Troponin Test Receives CE Mark

July 21, 2017

Singulex has received the CE Mark for its Singulex Sgx Clarity cTnl assay for the biomarker troponin.

The assay is indicated for use in conjunction with clinical evaluation for ruling out cardiac ischemia in patients suspected of having coronary artery disease.

The company will submit data for FDA clearance of the assay in 2018.

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