December 17, 2021 – BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) announced it has expanded the BD COR System to include a new MX instrument for high-throughput molecular testing for infectious diseases. The new instrument and its first test for STIs have been CE marked to the IVD directive 98/79/EC.
In addition to CE mark, the BD CTGCTV2 for BD COR System assay was also included on the Australian Register for Therapeutic Goods (ARTG) following review by Australia’s Medical Devices Regulator, the Therapeutic Goods Administration (TGA).
The new MX instrument is the final piece of the BD COR System, which also includes a PX instrument that can prepare diagnostic samples by automating appropriate pre-analytical processing steps and a GX instrument that can leverage the BD Onclarity HPV Assay with extended genotyping to screen for HPV infections.
The first test available on the MX instrument is the BD CTGCTV2 for BD COR System, which is designed to use a single test to detect the three most prevalent non-viral sexually transmitted infections — Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and Trichomonas vaginalis (TV).
The MX instrument is built off the BD MAX System molecular PCR (polymerase chain reaction) technology platform, a medium-throughput system typically found in hospital labs, and BD intends to leverage the BD MAX System menu of infectious disease tests to create assays that can be performed in high-throughput central reference labs on the BD COR System.
The BD COR MX/PX System allows 1,700 specimens to be loaded, with onboard capacity for reagents and samples that provide more than six hours of unimpeded system processing and up to 1,000 sample results in 24 hours.
The BD COR System integrates and automates the complete molecular laboratory workflow from sample processing to diagnostic test result. The BD COR PX instrument integrates and automates the sample workflow for diagnostic specimens and assays, preparing the samples by performing the appropriate pre-analytical processing steps and automatically delivering the samples to the MX or GX instruments for molecular analysis.
The MX instrument will perform the analytical steps of the BD CTGCTV2 molecular assay, including extraction, amplification and detection. Additional assays for the MX module are in development. The GX module is exclusively used for HPV testing. The BD COR PX/GX System has been in use in Europe since 2019.
The system is modular and scalable, and designed to address multiple needs within laboratories for expanding molecular testing and increasing test volumes. The system enables the processing of samples directly from liquid-based cytology vials and other BD sample collection devices, and the creation of molecular aliquot tubes and assay testing — automating labor-intensive and error-prone manual processes.