Cepheid Announces FDA-Cleared Test for Detection of Carbapenem Resistance Genes

Cepheid announces that it has received clearance from the Food and Drug Administration (FDA) to market Xpert® Carba-R, a qualitative in vitro diagnostic test for fast, accurate, and reproducible identification of five distinct families of carbapenem resistance genes that together represent the most common carbapenemases identified globally, including KPC, NDM, VIM, OXA-48 and IMP.  Xpert Carba-R is the first FDA-cleared test for detection and differentiation of carbapenemase genes in pure bacterial isolates, previously shown to be non-susceptible to carbapenem antibiotics, which may be cultured from a wide range of clinical specimens, including blood cultures, urine, respiratory samples, abscesses and swab surveillance specimens. 
  
"The emergence of carbapenemase producing organisms, known as CPOs, represents a significant global healthcare risk since these bacteria are resistant to many of the beta-lactam antibiotics used for empiric therapy for gram negative infections. These resistance genes are highly transmissible from one bacterial species to another, leading to well-documented outbreaks associated with high morbidity and mortality," says David Persing, MD, PhD, Cepheid's chief medical and technology officer. "Carbapenem resistance mechanisms can be extremely difficult to characterize with conventional laboratory procedures.  Now, with a bacterial isolate and less than a minute of hands-on time, Xpert Carba-R delivers a result in under an hour, allowing timely detection and differentiation of the most prevalent carbapenemase genes associated with CPO outbreaks to support infection control efforts."
  
"The availability of a rapid and accurate molecular test for the most prevalent mechanisms of carbapenem resistance represents an important addition to the limited tools the laboratory has available to fight the emergence of multidrug resistant organisms, like CPOs," says Paul Schreckenberger, PhD, director of microbiology at Loyola University Medical Center. "Knowing which carbapenemase gene is present in a resistant isolate helps the hospital identify and manage outbreaks and can also be valuable for monitoring the spread of multi-resistant bacteria among hospital populations considered most at risk." 
  
Xpert Carba-R will begin shipping in the United States later this month, and is the 20th US-IVD test available to run on Cepheid's GeneXpert® System, the world's leading molecular diagnostic platform with more than 10,000 systems installed globally. Xpert Carba-R is the latest diagnostic solution from Cepheid to help infection control professionals fight antimicrobial resistance, building on a portfolio that already includes MRSA, C. difficile and VRE.  The product's availability in the United States is particularly timely, following publication of a study last week from the Centers for Disease Control and Prevention (CDC) citing carbapenem-resistant Enterobacteriaceae as an urgent threat and emphasizing the prevention of antibiotic-resistant healthcare-acquired infections as an important strategy for reducing the impact of antibiotic-resistant bacteria on human health, including the prevention of sepsis and death.  
  
Source: Cepheid

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