Becton Dickinson Gets FDA Clearance for Its Molecular Diagnostic Platform

Becton Dickinson (BD) has received the FDA’s 510(k) clearance for its BD COR MX/PX infectious disease molecular diagnostics platform.

The platform is designed to automate the workflow from sample processing to test results for large, high-throughput laboratories.

The first test available on the new system is the BD CTGCTV2 assay, a single test that detects the three most prevalent nonviral sexually transmitted infections (STI) — Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and Trichomonas vaginalis (TV). The three STIs can cause a range of negative patient outcomes, from pregnancy complications to increased risk of HIV.

The COR in BD COR “is not an acronym, nor does it stand for anything per se,” a BD spokesperson said. “But molecular diagnostics is at the heart of much of our work, and “cor” is Latin for heart; it also implies the center (core).” MX and PX are also not acronyms, but MX alludes to “molecular” and PX alludes to “pre-analytical,” the spokesperson said.