BD (Becton, Dickinson and Company), a leading global medical technology company, 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 sexually transmitted infections have been CE marked to the IVD directive 98/79/EC.
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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 MX instrument is built off the proven BDMAX™ System molecular PCR (polymerase chain reaction) technology platform, a medium-throughput system typically found in hospital labs, and BD intends to leverage the BDMAX™ 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 first test available on the MX instrument is the BD CTGCTV2 for BDCOR™ 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).
In addition to CE mark, the BD CTGCTV2 for BDCOR™ 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 BDCOR™ PX/GX system is already used at laboratories across Europe and in Israel, helping to improve diagnostics and positively impact patient care,” said Nikos Pavlidis, vice president of Molecular Diagnostics at BD. “The availability of the MX instrument expands the use of the platform and automates testing for an expanding list of high-demand, essential assays for women’s health and STI testing using multiplex PCR assay design, starting with BD’s CTGCTV2 test.”