Franklin Lakes, New Jersey-based BD designed the BD COR MX instrument option, which now has FDA 510(k) clearance, for molecular diagnostics for infectious disease.
According to a news release, the first test available on the instrument option for the BD COR system is the BD CTGCTV2 molecular assay — a single test for detecting three sexually transmitted infections (STIs): Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and Trichomonas vaginalis (TV).
BD COR MX/PX integrates and automates the complete molecular laboratory workflow from sample processing to diagnostic results for high throughput labs, the company said. According to BD, the platform eliminates the need to sort specimens, giving lab techs the ability to have very little interaction with the specimen and free up time for other lab processes.
In total the BD COR MX/PX system allows for the loading of 1,700 specimens, with onboard capacity for reagents and samples providing more than seven hours of unimpeded system processing. The company said it can deliver up to 1,000 sample results in 24 hours and offers dual DNA targets for CT and GC detection in the same sample and assay to reduce false positives.
Collection options for the assay include self-collection in a clinical setting, vaginal/endocervical swab, urine (both male and female) and liquid-based cytology.
BD COR also includes a GX instrument that uses the BD Onclarity HPV assay with extended genotyping for HPV infections. The company is developing more assays for the MX instrument that range beyond women’s health and STI testing.
“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,” President of Integrated Diagnostic Solutions Brooke Story said in the release. “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 announcement comes a day after the company announced the expansion of a strategic partnership with Babson Diagnostics to move blood sample collection into new care settings, including enabling patients to collect blood samples at home for diagnostic testing.