Xpert™ Test for C.difficile now CE Marked

Cepheid have released the 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.

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.'