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Becton Dickinson High-Throughput MDx Module, Triplex STI Test Get FDA 510(k)Clearance

NEW YORK – Becton Dickinson has received 510(k) clearance from the US Food and Drug Administration for the MX molecular diagnostics module along with a triplex assay for chlamydia, gonorrhea, and trichomonas. The test and instrument, which is part of the modular BD Cor system, are now commercially available in the US, BD announced on Wednesday.

The BD Cor consists of a sample prep module called PX and a dedicated HPV screening module called GX. It launched with these first two components in Europe in 2019 and debuted in the US last year. The MX module is a fully automated, high-throughput molecular diagnostics instrument for the Cor system, akin to the BD Max system. The MX module obtained the CE mark last year.

The BD CTGCTV2 molecular assay is a single test that detects the three most prevalent non-viral sexually transmitted infections: Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV). Collection options for the BD CTGCTV2 assay include self-collection in a clinical setting, vaginal or endocervical swab, male and female urine, and liquid-based cytology.

The BD Cor MX module, in combination with the PX module, allows for loading of 1,700 specimens with onboard capacity for reagents and samples providing more than seven hours of unimpeded system processing, BD said. The system can deliver as many as 1,000 sample results in 24 hours, and eliminates the multiple manual handling steps each shift that are traditionally required. The CTGCTV2 assay also uses dual DNA targets for CT and GC detection, which can help reduce false positives, BD said.

"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."

The system can be adapted to include the GX module, which leverages the BD Onclarity HPV assay with extended genotyping to screen for HPV infections.

BD said that additional assays for the MX instrument beyond women's health and STI testing are in development.