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On-Demand Molecular Diagnostic Test For Clostridium Difficile Launched

Ruzanna Harutyunyan's picture

Cepheid (Nasdaq: CPHD) today announced the release of Xpert C. difficile as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. For the first time, European hospitals will have access to a reliable, rapid test for Clostridium difficile, which simultaneously detects and identifies the commonly occurring strains and specifically identifies the more virulent Type 027 strain. The new 50-minute test runs on Cepheid's GeneXpert System, the world's leading HAI molecular testing platform, and eliminates the need for multiple tests using less reliable methods.

Based on published incidence rates, there are approximately 58,000 annual cases of Clostridium difficile-associated disease (CDAD) in the United Kingdom. A recent health statistics report on deaths involving C. difficile in England and Wales showed the annual number of deaths rising by approximately 55 percent to nearly 8,500 in 2007.

"C. difficile is a horrific infection for a patient to deal with, especially as it is most common amongst the elderly and infirm, or those who are already seriously ill and have a weakened immune system," said Professor Richard James, Director of the Centre for Healthcare Associated Infections, University of Nottingham. "C. difficile infected patients are a source of transmission to other patients, therefore it is important that infected patients are detected as early as possible in order to minimize the impact of the outbreak. Rapid molecular testing, providing wholly accurate results in less than an hour, when combined with isolation of infected patients, provides an important new weapon in our battle against healthcare associated infections."

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The more virulent C. difficile Type 027 strain has been reported in 16 European countries through June of this year, responsible for outbreaks in Belgium, Germany, Finland, France, Ireland, Luxembourg, The Netherlands, Switzerland and the United Kingdom. C. difficile infections are estimated to cost the National Health Service (NHS) up to 8,000 pounds Sterling per patient and more than 200m pounds each year.

"The ability to specifically identify the 027 strain will enable tracking of local hospital outbreaks of this strain, which is likely to be of significant value to infection control professionals in curbing the spread of C. difficile," said Dr. David Persing, Cepheid's Executive Vice President, Chief Medical & Technology Officer. "Xpert C. difficile comprises the attributes of high accuracy and rapid, on-demand results that are of the greatest importance in controlling transmission of this emerging pathogen."

CDAD has become more common and is increasing in severity, with an attributable mortality of 6-15 percent. C. difficile is acquired via contact with infected patients or from exposure to contaminated hospital environments. C. difficile disease can range in severity from mild to sever diarrhea, pseudomembranous colitis, sepsis, and death. If C. difficile infection is detected early, studies show reduced length of stay, improved patient outcomes, and significant cost savings for hospitals.

About the GeneXpert System Molecular Diagnostic Platform

The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert System is the only system to combine on- board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands of any clinical environment.