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.

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May
09
Sponsored by
SeraCare

This webinar is the last in a four-part series highlighting real-world examples of how some lab directors are bringing validated next-generation sequencing-based tests to the clinic.