FDA News

FDA approves Xpert Carba-R assay for detection of carbapenem resistance genes

Cepheid has received clearance from the FDA to market its Xpert Carba-R assay, a qualitative in vitro test used to identify carbapenem resistance genes such as Klebsiella pneumoniae carbapenemase, New Delhi metallo-beta-lactamase, Verona integron-encoded metallo-beta-lactamase, imipenemase metallo-beta-lactamase, and OXA-48, according to a press release.

“The emergence of carbapenemase-producing organisms, known as CPOs, represents a significant global health care risk since these bacteria are resistant to many of the beta-lactam antibiotics used for empiric therapy for gram-negative infections,” David Persing, MD, PhD, chief medical and technology officer for Cepheid, said in the release. “These resistance genes are highly transmissible from one bacterial species to another, leading to well-documented outbreaks associated with high morbidity and mortality.”

The Xpert Carba-R assay is the first to be cleared by the FDA for the identification of carbapenemase genes in various clinical specimens, including blood, urine and respiratory samples, abscesses and swab surveillance specimens, the release said. The test is capable of producing results in less than 1 hour, according to Persing.

Paul Schreckenberger, PhD

Paul Schreckenberger

"The availability of a rapid and accurate molecular test for the most prevalent mechanisms of carbapenem resistance represents an important addition to the limited tools the laboratory has available to fight the emergence of multidrug resistant organisms, like CPOs,” Paul Schreckenberger, PhD, director of microbiology at Loyola University Medical Center, said in the release. “Knowing which carbapenemase gene is present in a resistant isolate helps the hospital identify and manage outbreaks and can also be valuable for monitoring the spread of multiresistant bacteria among hospital populations considered most at risk.”

The test is expected to begin shipping in the United States this month, according to the release. It is the 20th in vitro diagnostic test that runs on Cepheid’s GeneXpert System.

Disclosures: Persing is an employee of Cepheid. Schreckenberger is a scientific consultant for Cepheid.

Cepheid has received clearance from the FDA to market its Xpert Carba-R assay, a qualitative in vitro test used to identify carbapenem resistance genes such as Klebsiella pneumoniae carbapenemase, New Delhi metallo-beta-lactamase, Verona integron-encoded metallo-beta-lactamase, imipenemase metallo-beta-lactamase, and OXA-48, according to a press release.

“The emergence of carbapenemase-producing organisms, known as CPOs, represents a significant global health care risk since these bacteria are resistant to many of the beta-lactam antibiotics used for empiric therapy for gram-negative infections,” David Persing, MD, PhD, chief medical and technology officer for Cepheid, said in the release. “These resistance genes are highly transmissible from one bacterial species to another, leading to well-documented outbreaks associated with high morbidity and mortality.”

The Xpert Carba-R assay is the first to be cleared by the FDA for the identification of carbapenemase genes in various clinical specimens, including blood, urine and respiratory samples, abscesses and swab surveillance specimens, the release said. The test is capable of producing results in less than 1 hour, according to Persing.

Paul Schreckenberger, PhD

Paul Schreckenberger

"The availability of a rapid and accurate molecular test for the most prevalent mechanisms of carbapenem resistance represents an important addition to the limited tools the laboratory has available to fight the emergence of multidrug resistant organisms, like CPOs,” Paul Schreckenberger, PhD, director of microbiology at Loyola University Medical Center, said in the release. “Knowing which carbapenemase gene is present in a resistant isolate helps the hospital identify and manage outbreaks and can also be valuable for monitoring the spread of multiresistant bacteria among hospital populations considered most at risk.”

The test is expected to begin shipping in the United States this month, according to the release. It is the 20th in vitro diagnostic test that runs on Cepheid’s GeneXpert System.

Disclosures: Persing is an employee of Cepheid. Schreckenberger is a scientific consultant for Cepheid.