Cepheid has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Carba-R, a qualitative in vitro diagnostic test for fast, accurate, and reproducible identification of 5 distinct families of carbapenem resistance genes that together represent the most common carbapenemases identified globally.
The company announced the news in a Mar. 9 press release.
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,” said David Persing, M.D., Ph.D., Cepheid’s Chief Medical and Technology Officer. “These resistance genes are highly transmissible from one bacterial species to another, leading to well-documented outbreaks associated with high morbidity and mortality.”
Xpert Carba-R will begin shipping in the United States later this month.
