First Fully Integrated LC-MS System for Clinical Diagnostics Announced by SCIEX

The SCIEX Topaz™ System lowers the barriers to adoption of LC-MS to clinical diagnostic labs by making this powerful technology accessible to all users

Framingham, MA — SCIEX Diagnostics, the in vitro diagnostics division of SCIEX, a global leader in mass spectrometry in the life sciences industry, announced today the launch of the first fully integrated LC-MS system for clinical diagnostics, the SCIEX Topaz™ System. The Topaz System is designed specifically to meet the unique needs of the clinical diagnostic lab, lowering the barriers to adoption of LC-MS and making it accessible to the entire clinical lab staff. 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. According to the CDC, LC-MS technology is the gold standard method for testing Vitamin D, as it offers greater specificity and less cross-reactivity over immunoassay methods. The Vitamin D 200M Assay Kit has successfully met the rigorous performance criteria established by the CDC’s Vitamin D Standardization-Certification Program (VDSCP). The assay individually quantitates both Vitamin D2 and D3 while also separating out the D3 epimer, providing the specificity to deliver an accurate measurement of Vitamin D status.

FDA-cleared (via the de novo pathway) LC-MS based Vitamin D assay kit, the Vitamin D 200M Assay, exclusively for the SCIEX Topaz™ System

SCIEX Topaz™ System

The Topaz System offers the ultimate in flexibility with 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, so lab staff can be up and running quickly. The Topaz System enables clinical labs to rapidly expand their testing services and bring previously outsourced tests in-house, realizing cost savings along with gold-standard accuracy, in less time, with less complexity - all for the benefit of delivering quality patient care.

“SCIEX set out with the goal to making mass spectrometry simple for clinical labs, and the outcome is the first integrated LC-MS-based IVD system that is open by design and closed when you need it,” said Dr. Aaron Hudson, Sr. Director and GM of SCIEX Diagnostics. “The innovative ClearCore MD software simplifies and streamlines workflows and method development, bringing the power of SCIEX LC-MS technology to the hands of the routine user. In conjunction with the first FDA-cleared (via the de novo pathway) Vitamin D LC-MS assay, the Topaz system empowers a lab to do more, save more, and deliver more confident results to support clinicians.”

“The Topaz System from SCIEX Diagnostics is the LC-MS that mid-sized clinical labs have been waiting for,” said Dr. Jim Ritchie Professor, Pathology & Laboratory Medicine at the Emory University School of Medicine. “I believe this system is approaching a stage of automation close to that of a chemistry analyzer, in many ways. It was easy to train Med-Techs on and easy to learn to operate, adopt, and sustain in our clinical lab. We believe it’s primed to set the new standard for ease of use.”

The introduction of the Topaz System further expands the portfolio of clinical diagnostic solutions offered by the diagnostic companies of Danaher Corporation, which include Beckman Coulter, Cepheid, Leica Biosystems, Radiometer, and SCIEX Diagnostics. The breadth of this portfolio extends from the established to novel diagnostic technologies for clinical and anatomic pathology laboratories and point-of-care testing. With a rich history and a tradition of innovation, the diagnostic companies of Danaher remain committed to developing of new and unique diagnostic approaches for improved, quality patient care, and to helping the healthcare systems build comprehensive and efficient diagnostic services with a high degree of automation, accuracy through standardization, and data connectivity.

To learn more about the SCIEX Topaz System: visit SCIEX booth at AACC July 30 – August 03 in San Diego, U.S., or MSACL September 10 – 14 in Salzburg, Austria.