Singulex has received the CE mark for its Sgx Clarity cTnI assay, an ultra-sensitive test that measures cardiac troponin at lower levels than most existing assays. The test is performed on Singulex’s Sgx Clarity system, a fully automated diagnostics platform that uses the company’s proprietary Single Molecule Counting (SMC) technology, which Singulex says is up to 100 times more sensitive than current immunoassay methods. This technology works by combining patient samples that contain the analyte of interest with micro-particles coated with fluorescent antibodies. After incubation and washing, the eluate is passed through a small chamber with a laser, where any single fluorescently-labeled molecules will give off a bright flash of light. The sum of these flashes serves as an approximation of the concentration of the analyte in the original sample. SMC has been studied in trials involving more than 100,000 subjects. Singulex plans to submit the Sgx Clarity system and accompanying cTnI assay for regulatory clearance in the U.S. and expects approval from the Food and Drug Administration in 2018.