Cepheid Launches First On-Demand Molecular Diagnostic Test for Clostridium Difficile Into Europ...( Test Simultaneously Identifies and D...),Health

Test Simultaneously Identifies and Differentiates More Virulent 027 Strain

from Common Strains

SUNNYVALE, Calif., Nov. 10 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today announced the release of Xpert(TM) 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(R) 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."

The more virulent C. difficile Type 027 strain has been reported in 16 European coun
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