FDA Clears Expanded Claims for ‘Superbug’ Test

Xpert® Carba-R now FDA-cleared to aid clinicians in determining appropriate therapeutic strategy for pure colony specimens

SUNNYVALE, CALIF. — May 15, 2018 — Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for expanded claims for Xpert® Carba-R, an on-demand
molecular test for rapid and accurate detection of carbapenemase-producing Gram-negative bacteria. The additional claims extend use to analysis of perirectal swab specimens and allow use of Xpert Carba-R test results to guide therapeutic strategies for pure colonies.

“Controlling the spread of carbapenemase-producing organisms in healthcare settings requires rapid recognition, coordinated surveillance, effective infection prevention activities, and a strong commitment to antimicrobial stewardship,” said Dr. Fred C. Tenover, Cepheid’s Vice President for Scientific Affairs and former Director of CDC’s Office of Antimicrobial Resistance. “The addition of perirectal swab specimens to the product label should facilitate active surveillance testing programs, while the ability to use Xpert Carba-R results for therapeutic strategies should enhance antimicrobial stewardship efforts, especially in hospitals struggling with the spread of multidrug-resistant organisms.”

Carbapenemase-producing CRE are currently believed to be primarily responsible for the increasing spread of CRE in the United States and have been targeted by the CDC for aggressive prevention measures.1 Detection and differentiation of high-risk patients with Xpert Carba-R can alert clinicians and infection preventionists quickly to the presence of gene sequences associated with carbapenem non-susceptibility in gram-negative bacteria, including Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii. Rapid detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences from pure colonies helps clinicians optimize patient management and direct therapeutic strategy. Perirectal and rectal swabs are not intended to direct therapeutic strategy.


1. http://www.cdc.gov/hai/organisms/cre/definition.html


About Cepheid

Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and
tests. By automating highly complex and time-consuming manual procedures, the company’s solutions deliver a better way for institutions of any size to perform sophisticated molecular testing in virtually any
setting. Through a strong foundation in innovation, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and
cancer. For more information, visit http://www.cepheid.com.