Beckman Coulter Diagnostics has obtained CE marking for the VERIS MDx system and VERIS human cytomegalovirus (CMV) assay, which is a key milestone in the expansion of the company’s presence in molecular diagnostics. The VERIS MDx system is a fully automated, random-access molecular diagnostics system for the quantitative and qualitative analysis of molecular targets from patient specimens.
The VERIS system integrates key steps in molecular diagnostics to streamline workflow and system management, while also processing critical short turnaround time (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 laboratory.
The VERIS CMV assay is a polymerase chain reaction (PCR) assay designed for the quantitative determination of CMV DNA from human plasma. When used in conjunction with clinical presentation and other laboratory findings, the assay aids in monitoring CMV viral load.
“After extensive research and development, Beckman Coulter has applied its expertise in diagnostics with in-depth knowledge of workflow to bring molecular diagnostics to the clinical laboratory,” said Richard Creager, senior vice president, Molecular Diagnostics, 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.”
Beckman Coulter is committed to the ongoing development of assays to expand the VERIS infectious disease portfolio and plans to submit for CE marking on assays for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and hepatitis B virus (HBV) in 2014.
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