Automated molecular diagnostic system
The BD COR System from BD (Beckton, Dickinson and Company) is an automated, high throughput molecular diagnostics system developed for large capacity laboratories. The modular and scalable design addresses lab needs to expand molecular testing offerings and increase test volumes by integrating and automating the complete molecular laboratory workflow. The system allows samples to be processed directly from liquid-based cytology vials and is capable of running the diagnostic workflow from pre-analytical processing to test result, unlike other automated molecular diagnostic platforms. As offerings expand, the system will provide a solution for a menu of clinically differentiated diagnostic assays for infectious diseases. It has on-board capacity for reagents and samples to provide up to 360 results in eight hours of system processing, eliminating multiple technologist interactions per shift. Currently, the BD COR System is CE-IVD marked. It 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 labour-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 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). Different configurations of the test are CE marked and FDA approved.