Company News: Agena Bioscience Launches CE-IVD System For Hospitals And Diagnostic Laboratories In Europe
– MassARRAY® System with Chip Prep Module receives CE-IVD marking for general in vitro diagnostic use in Europe
Agena Bioscience today announced the European launch of the MassARRAY® System with CHIP Prep Module (CPM), marketed as a CE-IVD product under the Directive 98/79/EC for in vitro diagnostic medical devices.
The MassARRAY Dx product offers clinical laboratories a unique combination of reliability, sensitivity, ease of use, and cost-effectiveness for targeted genetic testing. The multiplexing feature of MassARRAY supports assays that interrogate multiple biomarkers in a single reaction, which reduces the cost and turnaround time compared with other diagnostic methods. The system enables high-throughput, accurate detection of SNPs, INDELs, and copy number variations across a variety of genetic applications, including mutation profiling for solid tumors and highly sensitive liquid biopsy analysis, and comprehensive pharmacogenomics profiling. The flexibility and scalability of the platform facilitate easy development of custom panels and validation across large numbers of samples.
“This is good news and a new step for this high performing in vitro diagnostic (IVD) device. It will facilitate implementation in clinical labs and accreditation,” said Dr.Pierre-Jean Lamy, Directeur Général, Biologiste Médical at Labosud Oc Biologie.
“This is another great milestone in Agena’s global strategy to grow the clinical business by offering laboratories a highly effective diagnostic platform that can support the rapidly evolving needs of this market,” said Peter Dansky, Chief Executive Officer of Agena Bioscience. “In addition to the well-established performance of the MassARRAY System, the Chip Prep Module now adds increased ease-of-use to the overall workflow”.
The new CE-IVD marked MassARRAY System with Chip Prep Module joins the company’s growing line of in vitro diagnostic devices for certain European countries, including the MassARRAY Dx Analyzer 4, MassARRAY Dx Nanodispenser, MassARRAY Dx Colon Panel and MassARRAY Dx Lung Panel. These are sold exclusively in Europe for diagnostic use, and are not available for sale in the United States.