![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Becton Dickinson Gets FDA Clearance for Its Molecular Diagnostic Platform
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.
Upcoming Events
-
21Oct