Cepheid Announces First FDA-Cleared Test for Detection of Carbapenem Resistance Genes in Isolates of Multidrug Resistant 'Superbugs'

Xpert Carba-R Results in Less Than an Hour Help to Prevent and Manage Outbreaks

SUNNYVALE, Calif., March 9, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced that it 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, 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.