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Sciex Receives CE Mark for Topaz System

NEW YORK (360Dx) – Sciex announced last week at the Association for Mass Spectrometry: Application to the Clinical Lab annual European meeting that its Topaz clinical LC-MS/MS system has received the CE mark, making it available for clinical use in the EU.

Based on Sciex's existing 4500MD LC-MS system, the platform is a simplified and streamlined instrument targeting hospital labs and other facilities that are interested in using mass spec for clinical assays but that don't necessarily have the resources and expertise the technology has traditionally required.

The system can be used for both in vitro diagnostic kit assays from Sciex or other providers and laboratory-developed tests.

"Sciex set out with the goal of making mass spectrometry simple for clinical labs, and the outcome is the integrated LC-MS-based IVD system that is open by design and closed when you need it," Aaron Hudson, senior director and GM of Sciex Diagnostics, said in a statement.

The announcement follows the introduction in July of a US Food and Drug Administration-cleared version of the platform as well as an FDA-cleared Vitamin D assay for use on the system. Sciex has not released a CE-marked Vitamin D assay for the EU version of the platform.