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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Apr 14, 2011

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Cepheid said this week that it has received clearance from the US Food and Drug Administration to market its Xpert C. difficile/Epi test.

Cepheid's first Xpert C. difficile test, which only detects C. difficile, has been available in the US since July 2009. The newly approved test additionally and simultaneously identifies the epidemic strain of C. difficile, also known as 027, NAP1, or BI, Cepheid said.

"Compared to less-virulent strains, C. difficile 027 strains produce higher levels of spores, which pose greater infection control challenges," Cepheid CEO John Bishop said in a statement. Bishop also noted that there is a growing body of evidence that the 027 strain is associated with more frequent relapses and ultimately higher mortality rates.

The Xpert C. difficile/Epi test, which runs on the GeneXpert system, is Cepheid's tenth Xpert test to receive FDA clearance. It is expected to be available for shipment in mid-May, the company said.

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