Molecular diagnostics firm Cepheid has secured approval from the US Food and Drug Administration (FDA) for its qualitative in vitro diagnostic test, Xpert Carba-R.
Xpert Carba-R has been developed to identify carbapenem resistance genes in isolates of multidrug resistant superbugs.
The test will be used to identify five families of carbapenem resistance genes such as KPC, NDM, VIM, OXA-48 and IMP.
Cepheid said that the test is the first FDA-cleared test for detection and differentiation of carbapenemase genes in pure bacterial isolates, earlier demostrated to be non-susceptible to carbapenem antibiotics.
These can be cultured from different clinical specimens, including blood cultures, urine, respiratory samples, abscesses and swab surveillance specimens.
Cepheid chief medical and technology officer Dr David Persing said: "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."
Xpert Carba-R, which will be available later this month, is the 20th US-IVD test available to run on the firm’s GeneXpert system.