USA – BD (Becton, Dickinson and Company) a global leader in medical technology, has announced the FDA approval of its new, fully automated, high-throughput infectious disease molecular diagnostics platform in the United States.
The medtech giant recently received FDA clearance for the third component in its Cor diagnostics platform, it announced this week, and has already begun rolling out the new BD Cor MX instrument across the United States.
On the Cor platform, the MX system joins the previously cleared PX and GX instruments. Overall, the platform is intended to fully automate the workflow in molecular diagnostics labs, from sample processing to result delivery—all at a relatively fast and large scale.
Brooke Story, president of integrated diagnostic solutions at 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.”
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.
Along with the release of the MX component, BD was given the go-ahead to release the instrument’s first assay: a three-in-one test that detects the most common non-viral sexually transmitted infections, including chlamydia, gonorrhea, and trichomoniasis.
Following CE mark approval late last year, both the MX system and the triple STI test have already been launched across the pond.
When combined with the BD Cor PX and GX systems, which both received FDA clearances last summer, the MX platform can accept 1,700 samples for testing.
It can run for up to seven hours without interruption before needing more samples or reagents to continue processing.
Thanks to a combination of robotics and automated algorithms, the system can generate up to 1,000 test results every 24 hours, largely without the need for hands-on supervision from lab workers.
The entire Cor platform is designed to be tailored to the needs of each lab. Each of the MX, PX, and GX components is modular and scalable, which means that a lab could double up on one instrument while foregoing another if necessary.
In addition to the new STI test, the combined platform can also run BD’s Onclarity HPV assay, which was cleared alongside the GX instrument.
BD said it is already working on more molecular tests that could be automated by the system, including ones that aren’t related to women’s health or STI testing.
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