Becton, Dickinson, and Co (BD), Franklin Lakes, NJ, has recently announced that the BD Cor system for automated molecular diagnostic testing has been granted the CE mark and is now available in Europe.
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 assays, while decreasing manual user interactions. The system is not yet available for sale in the United States or other markets with additional registration requirements.
According to the company, the BD Cor 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 Cor system integrates and automates the entire molecular laboratory workflow, from preanalytical processing to diagnostic test result. The system automates 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.
Initially, the BD Cor system will be available with the company’s Onclarity HPV assay for the detection and extended genotyping of human papilloma virus (HPV). The Onclarity HPV assay detects and identifies 14 high-risk HPV types and provides genotyping information from cervical cancer screening specimens collected in a BD SurePath vial and Hologic PreservCyt solution (not authorized in the United States). The assay can be used in accordance with clinical guidelines and regulatory authorization as part of a comprehensive approach to cervical cancer prevention. Different configurations of the test are CE marked and FDA approved.
“The launch of the BD Cor system is an important milestone on our molecular diagnostics roadmap, allowing us to offer preanalytical automation and high-throughput molecular testing to our largest laboratory customers,” says 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.”
Developed for large-capacity laboratories, the BD Cor system is modular and scalable, and designed to address multiple laboratory needs for expanding molecular testing and increasing test volumes. The system takes less than 15 minutes to load, and can produce 360 test results in 8 hours. It has sufficient onboard capacity for reagents and samples to provide 6 to 8 hours of system processing, eliminating multiple technologist interactions per shift.
Over the coming years, the company plans to continue seeking regulatory authorization to sell the BD Cor system around the world, while expanding the system’s menu to include many other assays for infectious diseases. Assays for gastrointestinal disorders and sexually transmitted diseases will be available in the near future.
For more information, visit BD.