CE Mark for VERIS MDx System and CMV Assay Attained

Beckman Coulter Diagnostics has obtained CE Mark for the VERIS MDx System and VERIS human Cytomegalovirus (CMV) assay. Attaining CE Mark on the VERIS MDx System and the VERIS CMV assay are key milestones in the expansion of Beckman Coulter’s presence in molecular diagnostics.

“After extensive research and development, Beckman Coulter has applied its expertise in diagnostics with our in-depth knowledge of workflow to bring molecular diagnostics to the clinical laboratory,” said Richard Creager, Senior Vice President, Molecular Diagnostics Business Unit, and Chief Scientific Officer at Beckman Coulter Diagnostics. “We have spent tremendous effort on understanding the needs of molecular laboratory professionals to develop a system that simplifies molecular diagnostic testing, while delivering the results that patients and clinicians need.”

The VERIS MDx System is a fully automated, random access molecular diagnostics system for the quantitative and qualitative analysis of molecular targets from clinical patient specimens. The VERIS system integrates key steps in molecular diagnostics to streamline workflow and system management, while also processing critical STAT samples and ensuring prompt delivery of results. By providing continuous access, one-step loading and individual test reporting, VERIS helps medical laboratory professionals advance and optimise the molecular diagnostics lab, by providing the control and freedom to give the right answer at the right time, for patients and physicians.

The VERIS CMV assay is a Polymerase Chain Reaction (PCR) assay designed for the quantitative determination of CMV deoxyribonucleic acid (DNA) from human plasma. When used in conjunction with clinical presentation and other laboratory findings, the VERIS CMV assay aids in monitoring CMV viral load.

Beckman Coulter is committed to the ongoing development of assays to expand the VERIS infectious disease portfolio and plans to submit for CE Mark on assays for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) in 2014.