In a recent press release, BD 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 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.
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.