SCIEX Diagnostics, the in vitro diagnostics division of SCIEX has introduced their first fully integrated LC-MS system for clinical diagnostics, the SCIEX Topaz™ System. The heart of the system lies within the innovative ClearCore™ MD software, a platform which simplifies and streamlines workflows and method development and incorporates features that enhance usability to help new users build proficiency quickly. In addition, the first FDA-cleared (via the de novo pathway) LC-MS based Vitamin D assay kit, the SCIEX Vitamin D 200M Assay, is for use on the SCIEX Topaz System.
The Topaz System provides both an open system for lab-developed tests (LDTs) and a closed system for running locked, pre-validated assays. In addition, a turnkey, FDA-cleared Vitamin D solution is available for immediate implementation. The Topaz System enables clinical labs to rapidly expand their testing services and bring previously outsourced tests in-house.