FDAnews
www.fdanews.com/articles/175721-cepheids-xpert-carba-r-receives-fda-clearance

Cepheid’s Xpert Carba-R Receives FDA Clearance

March 11, 2016

The FDA has granted clearance to Cepheid’s Xpert Carba-R, an in vitro diagnostic test that can detect five families of carbapenemase genes in pure bacterial isolates.

Xpert Carba-R produces a result in less than an hour, according to David Persing, Cepheid’s chief medical and technology officer.

Xpert Carba-R is considered the first FDA-cleared test designed to pinpoint and distinguish carbapenem resistance mechanisms. — Anisa Jibrell