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BD Gets CE Mark, Australian Regulatory Approval for New Cor MX Instrument

NEW YORK – Becton Dickinson announced on Friday that it has received the CE-IVD mark for a new instrument component of its BD Cor system. The instrument, called the MX, along with an assay for sexually transmitted infections, is also now included on the Australian Register for Therapeutic Goods following review by Australia's Therapeutic Goods Administration.

The MX instrument is the final component of the BD Cor system, which was launched with its first two components in Europe in 2019 and recently also debuted in the US.

The modular and scalable system also includes an instrument called the PX for automated pre-analytical processing, as well as an instrument called the GX that performs the firm's the BD Onclarity human papillomavirus assay with extended genotyping to screen for HPV infections.

The STI assay on the MX detects and distinguishes Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV).

Nikos Pavlidis, VP of molecular diagnostics at BD, noted that the BD Cor PX/GX system is already used at laboratories across Europe and in Israel. "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," he said.

The MX is based on the BD Max technology, and BD said it 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 MX/PX configuration, specifically, allows 1,700 specimens to be loaded, with onboard capacity for reagents and samples that provide more than six hours of system processing with up to 1,000 sample results in 24 hours, "eliminating multiple technologist interactions currently required per shift," BD said.

The system is particularly well suited to laboratories requiring high throughput for sample results and high capacity, BD added. It also enables the processing of samples directly from liquid-based cytology vials and other BD sample collection devices, as well as the creation of molecular aliquot tubes and assay testing.