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Cepheid Gets CE IVD Mark for C. Difficile Test

NEW YORK (GenomeWeb news) – Cepheid has launched its molecular diagnostic test for Clostridium difficile as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices.
The PCR-based test runs on the company’s GeneXpert System, and it detects and identifies common strains of the C. difficile infection, including the virulent Type 027 strain that had been reported in 16 European countries through June.
C. difficile can cause severe gastrointestinal problems and is resistant to most antibiotics. The company said that there are roughly 58,000 detected C. difficile cases in the UK each year, and the number of deaths rose by around 55 percent to 8,500 in England and Wales in 2007.
"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,” said Richard James, director of the Centre for Healthcare Associated Infections at the University of Nottingham
David Persing, Cepheid’s executive VP and chief medical and technology officer, said in a statement that the ability to test for the 027 strain “will enable tracking of local hospital outbreaks,” which could “be of significant value to infection control professionals in curbing the spread of C. difficile.”

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