FDA Clears First Test for Detection of Carbapenem Resistance Genes in “Superbugs”

Shipments begin later this month

Cepheid has received clearance from the FDA to market Xpert Carba-R, a qualitative in vitro diagnostic test for rapid, 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. The test is designed to be run on Cepheid’s GeneXpert system.

Xpert Carba-R is the first FDA-approved test for the detection and differentiation of carbapenemase genes in pure bacterial isolates previously shown to be nonsusceptible to carbapenem antibiotics. These isolates may be cultured from a wide range of clinical specimens, including blood cultures, urine, respiratory samples, abscesses, and swab surveillance specimens.

Shipments of Xpert Carba-R in the U.S. will begin later this month. The product’s availability follows the publication of a study from the Centers for Disease Control and Prevention citing carbapenem-resistant Enterobacteriaceae as an urgent threat and emphasizing the prevention of antibiotic-resistant health care-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; March 9, 2016.