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Cepheid Gets CE-IVD Mark for MRSA/SA Nasal Assay

NEW YORK (GenomeWeb News) – Cepheid has received the CE-IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices for its Xpert MRSA/SA Nasal molecular diagnostic test.

The test, which simultaneously detects methicillin-resistant Staphylococcus aureus and methicillin-sensitive Staphylococcus aureus in less than one hour from a sample taken from the nasal carriage, is run on the firm's GeneXpert System. According to Cepheid, it is the 10th CE-IVD test for use on the system.

"With the addition of Xpert MRSA/SA Nasal, Cepheid now offers European clinicians the most comprehensive suite of on-demand molecular tests currently available to aid in the overall management of [hospital-acquired infections]," Cepheid CEO John Bishop said in a statement.

Cepheid noted that 29 million surgical procedures are performed annually in Europe, with approximately 2.6 percent of those patients developing surgical site infections. It said that its test would enable clinicians to determine pre-operative carrier status by detecting MRSA/SA and guide for the best course of treatment for colonized patients.

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