BD Launches Fully Automated, High-Throughput Infectious Disease Molecular Diagnostic Platform in the U.S.
BD has received 510(k) clearance from the FDA for its BD COR™ MX instrument, enhancing STI diagnostics capabilities. The first assay available detects Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. This system automates laboratory workflows, enabling the processing of 1,700 specimens and delivering up to 1,000 results in 24 hours. By reducing manual interactions, it aims to alleviate staff workloads, especially critical amidst ongoing healthcare staffing challenges. Future assays for women's health and other indications are in development.
- 510(k) clearance obtained for the BD COR™ MX instrument.
- System can process up to 1,700 specimens with results in 24 hours.
- Automation reduces manual labor, enhancing lab efficiency.
- None.
510(k) Clearance of BD COR™ MX Instrument Elevates Standard of Care for Sexually Transmitted Infections
FRANKLIN LAKES, N.J., May 12, 2022 /PRNewswire/ -- 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 planned beyond 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.
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 75,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com or connect with us on LinkedIn at www.linkedin.com/company/bd1/ and Twitter @BDandCo.
Contacts:
Media: Mela Sera, APR | Investors: Francesca DeMartino |
BD Public Relations | SVP, Head of Investor Relations |
443.824.8012 | 201.847.5743 |
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SOURCE BD (Becton, Dickinson and Company)
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