Molecular screening test to detect antibiotic-resistant bacteria receives FDA clearance

BD Biosciences, a leading global medical technology company, along with Check-Points Health B.V., have announced that FDA 510(k) clearance was obtained for a molecular screening test that detects antibiotic-resistant carbapenemase-producing organisms (CPOs) using the fully-automated BD MAX™ System.

The BD MAX™ Check-Points CPO assay provides detection of the five most common carbapenemase genes directly from the patient specimen in approximately 2.5 hours, as compared to traditional methods that can take up to 24 hours to confirm a negative or longer for a final positive result. Early detection of patients colonized with these organisms can provide the necessary information to implement proper infection control measures.

Together with the BD Phoenix™ CPO Detect Panels, BD provides solutions for screening and infection management to support clinical microbiology laboratories in detecting CPOs, and helping hospitals implement robust programs to address antimicrobial resistance.

“The launch of the BD MAX Check-Points CPO assay in the US is another example of BD’s commitment to helping prevent and reduce the spread of healthcare associated infections,” said Nikos Pavlidis, vice president and general manager, molecular diagnostics and women’s health for BD. “Our solutions for CPO detection and identification are an important part of our portfolio of products for infection prevention, diagnostics, and surveillance and monitoring that help hospitals combat antimicrobial resistance.”

This assay joins BD’s comprehensive healthcare-associated infections diagnostics portfolio, which aims to reduce transmission and outbreak of deadly pathogens. The BD MAX™ product menu also includes syndromic panels for gastrointestinal infections, as well as reproductive and sexually transmitted infections, which aid laboratory professionals in their efforts to deliver diagnostic results that inform clinicians to help enhance patient outcomes, while improving laboratory efficiency. The BD MAX™ system also features an open system capability, allowing for streamlined workflow of laboratory developed tests and for additional assays via BD partner collaborations.

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