FDA Clears Molecular Screening Test for Detection of Antibiotic-Resistant Bacteria

 BD (Becton, Dickinson and Company), a global medical technology company, along with Check-Points Health B.V., announced that the U.S. Food and Drug Administration 510(k) clearance of a molecular screening test for antibiotic-resistant carbapenemase-producing organisms (CPOs) on 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 two and a half 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 (AMR). 
 
“The launch of the BD MAX Check-Points CPO assay in the U.S. is another example of BD’s commitment to helping prevent and reduce the spread of healthcare associated infections (HAIs),” 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 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.
 
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of healthcare by developing technology, services, and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to accurately detect disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety, and expand access to healthcare. 
 
Check-Points is a privately owned diagnostics company in Wageningen, The Netherlands, and a developer and marketer of molecular assays for gram-negative drug-resistant bacteria. Check-Points offers a range of IVD and RUO products for the detection of carbapenemases, ESBLs and AmpCs. In addition, the Check&Trace product line allows for fast and reliable routine molecular confirmation and serotyping of Salmonella for food and veterinary diagnostics.