FDA clears BD's newest molecular diagnostics machine and its first test, a 3-in-one STI screener

When it comes to molecular diagnostics, BD is betting that three heads are better than one.

The medtech giant recently landed the FDA’s clearance for the third component in its Cor diagnostics platform, it announced this week, and has already begun the launch of the new BD Cor MX instrument throughout the U.S.

The MX system joins the previously cleared PX and GX instruments on the Cor platform. Altogether, the platform is designed to fully automate the workflow in molecular diagnostics labs, from processing samples to returning results—all done relatively rapidly and at a huge scale.

“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 at 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.”

Alongside the launch of the MX component, BD was also given the green light to roll out the instrument’s first assay: a three-in-one test that simultaneously looks for the most common non-viral sexually transmitted infections at once, including chlamydia, gonorrhea and trichomoniasis.

Both the MX system and the triple STI test have already launched across the pond, after securing CE mark approval late last year.

When integrated with the BD Cor PX and GX systems—both of which landed their own FDA clearances last summer—the MX platform can take on 1,700 samples for testing. It runs for up to seven hours at a time unimpeded, before requiring more samples or reagents to continue processing.

In total, the system churns out up to 1,000 test results every 24 hours, largely without requiring hands-on supervision from lab workers, thanks to a combination of robotics and automated algorithms.

The entire Cor platform is meant to be customized to an individual lab’s needs. Each of the MX, PX and GX components are modular and scalable, meaning that a lab could double up on one instrument, for example, while completely forgoing another if needed.

In addition to the new STI test, the combined platform can also run BD’s Onclarity assay for human papillomavirus, or HPV, which was cleared alongside the GX instrument. BD said it’s already developing even more molecular tests that could be automated by the system, including ones outside of the instrument’s current realm of women’s health and STI testing.