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BD Launches Fully Automated, High-Throughput Infectious Disease Molecular Diagnostic Platform in the U.S.

510(k) Clearance of BD COR™ MX Instrument Elevates Standard of Care for Sexually Transmitted Infections

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BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the U.S. launch of its new, fully automated, high-throughput infectious disease molecular diagnostics platform.

With 510(k) clearance from the U.S. Food and Drug Administration (FDA), the new BD COR™ MX instrument is a new analytic instrument option for the BD COR™ System.

The first test available on the new system is the BD CTGCTV2 molecular assay, a single test that detects the three most prevalent non-viral sexually transmitted infections (STIs) — Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and Trichomonas vaginalis (TV). These three STIs can include a range of negative patient outcomes, from pregnancy complications to increased risk of HIV.

The BD COR™ MX/PX System integrates and automates the complete molecular laboratory workflow, from sample processing to diagnostic test result for large, high-throughput labs. The BD COR™ System eliminates the need to sort specimens enabling the lab tech to have very little interaction with the specimen freeing up time for other critical lab processes.

Together, the BD COR™ MX/PX System allows 1,700 specimens to be loaded, with onboard capacity for reagents and samples that provide more than seven hours of unimpeded system processing.

The system is capable of delivering up to 1,000 sample results in 24 hours, eliminating multiple manual interactions per shift that were traditionally required. It also offers dual DNA targets for CT and GC detection together in the same sample and assay, which can help reduce false positives.

“Even before COVID-19, clinicians and laboratory technicians were faced with increasing workloads and patient needs, and now those challenges have been amplified significantly by the ongoing staffing shortages and further increased workloads caused by the pandemic,” said Brooke Story, president of Integrated Diagnostic Solutions for BD. “By automating labor-intensive and mundane error-prone processes, the BD COR™ MX/PX System allows lab technicians and clinicians to focus on higher value work.”

Collection options for the BD CTGCTV2 assay include self-collection (in clinical setting), vaginal/endocervical swab, urine (both male and female) and liquid-based cytology.

The BD COR™ System also includes a GX instrument, which leverages the BD Onclarity™ HPV Assay with extended genotyping to screen for HPV infections. The GX instrument coupled with the availability in the U.S. of the MX instrument, which was CE marked in 2021, expands the use of the platform and automates testing for a growing list of high-demand, essential assays for women’s health and STI testing. Additional assays for the MX instrument are in development and are plannedeyond women’s health and STI testing.

The BD COR™ System is fully automated, modular, and scalable instrument, designed to address multiple needs within laboratories to handle expanding molecular testing volumes. The BD COR™ System is particularly well-suited for laboratories requiring high throughput testing because of innovative automation, minimizing staff interaction by maximizing laboratory workflow efficiencies.

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