Automated BD COR™ System Achieves CE-IVD Status; Now Available in Europe
FRANKLIN LAKES, N.J., June 18, 2019 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the CE-IVDD certification of the BD COR™ System in Europe. The high throughput solution for infectious disease diagnostics sets a new standard in automation for molecular testing in core laboratories and other large centralized laboratories.
The BD COR™ System integrates and automates the complete molecular laboratory workflow from pre-analytical processing to diagnostic test result. The system will be initially available with the BD Onclarity™ HPV Assay for the detection and extended genotyping of human papilloma virus (HPV). The system enables the processing of samples directly from liquid based cytology vials, the creation of molecular aliquot tubes and assay testing, replacing labor-intensive and error-prone manual processes with automated ones.
Over the coming years, the company plans to continue seeking regulatory authorizations to sell the BD COR™ System around the world while expanding the content menu to include many other assays for infectious diseases.
"The launch of the BD COR System is an important milestone on our molecular diagnostics roadmap allowing us to offer pre-analytical automation and high throughput molecular testing to our largest laboratory customers," said Dave Hickey, president of Diagnostic Systems at BD. "Over the coming years, we look forward to building on this platform to expand our menu and configurations."
The BD COR™ System is modular and scalable, designed to address multiple laboratory needs for expanding molecular testing and increasing test volumes. It has on board capacity for reagents and samples that provide six to eight hours of system processing, eliminating multiple technologist interactions per shift.
About the BD COR™ System
The BD COR™ System is a fully automated molecular diagnostics platform for high capacity laboratory environments. It performs sample preparation and processing steps necessary to complete molecular assay workflows and decreases manual user interactions. The system is CE-IVD marked and is not yet available for sale in the U.S. or other markets with additional registration requirements. The BD Onclarity™ HPV Assay is the first assay available on the BD COR™ System.
About BD Onclarity™ HPV Assay
The BD Onclarity™ HPV assay detects and identifies 14 high-risk human papillomavirus (HPV) types and provides genotyping information from specimens collected for cervical cancer screening purposes in the BD SurePath™ Vial and in the Hologic PreservCyt® Solution (not approved in the United States). The assay can be used in accordance with clinical guidelines and within the scope of local regulatory authorizations as part of a comprehensive approach to cervical cancer prevention. Different configurations of the test are CE marked and FDA approved.
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of healthcare by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to healthcare.
SOURCE BD (Becton, Dickinson and Company)