NEW YORK (GenomeWeb) – Singulex said today that it has received the CE mark in Europe for its Sgx Clarity system. The Alameda, California-based immunodiagnostics firm will now start marketing its single-molecule counting instrument as an in vitro diagnostics system.
Singulex also plans to pursue the CE mark for its cardiac troponin I assay and plans to submit data to the US Food and Drug Administration for clearance in 2018.