FDA Clearance for BD's Phoenix™ Fully-automated Test for Carbapenemase-Producing Organisms
BD Becton, Dickinson and Company have announced the U.S. Food and Drug Administration 510(k) clearance of the BD Phoenix™ CPO detect test, which will allow hospitals to identify infections caused by carbapenemase-producing organisms (CPOs). The test may help hospitals contain the spread of antimicrobial resistance (AMR) by shortening the time it takes to detect CPOs, thereby enabling the earlier implementation of infection control procedures and the initiation of appropriate antibiotic therapies designed for treating these infections.
"The BD Phoenix™ CPO detect test is a completely new type of phenotypic test, and its range of automation and diagnostic capabilities is unmatched by all other currently marketed tests," said Kenneth S. Thomson, PhD, FIDSA, FAAM, FASM clinical professor of Pathology and Laboratory Medicine, University of Louisville School of Medicine. "It represents a significant advance in meeting an important clinical need for rapid detection of CPOs."
The BD Phoenix™ CPO detect test, currently available in two configurations as part of the BD Phoenix™ automated microbiology system, detects CPOs and depending on configuration, can provide the Ambler classification of the enzyme produced to help inform clinicians in appropriate therapy selection. The test is included on BD Phoenix™ gram-negative panels, allowing hospital labs to offer it as part of routine antibiotic susceptibility testing.
The test streamlines laboratory workflow by routine, concurrent testing of CPO and susceptibility to one panel. Conventional phenotypic methods for CPO detection can take up to 96 hours, whereas the BD Phoenix™ CPO detect test can accurately detect CPOs in under 36 hours.
"The BD Phoenix™ CPO detect test gives laboratories an accurate and cost-effective method to rapidly identify CPOs and support patient management," said Steve Conly, vice president, general manager of Microbiology for BD Diagnostic Systems. "Along with the BD Phoenix™ M50 instrument, this automated first-to-market, phenotypic test to detect CPOs, using the BD Phoenix™ system, expands the BD portfolio of solutions for identification and antimicrobial susceptibility testing and is another example of the company's commitment to providing solutions that help address the global burden of AMR."
All versions of the BD Phoenix™ CPO detect test will be available beginning in January 2019. Visit bd.com/ds for more information.
Date Published: 19th November 2018
Source article link: BD Diagnostic Systems