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Cepheid Gets FDA Clearance for MRSA/SA Molecular Test

NEW YORK (GenomeWeb News) – Cepheid has received US Food and Drug Administration clearance to market its Xpert MRSA/SA Skin and Soft Tissue Infection test, the firm said today.
 
The molecular test, which runs on the firm’s GenXpert System, is used for rapidly identifying methicillin-resistant Staphylococcus aureus and Staphylococcus aureus in skin and soft tissue infections. Like its Xpert MRSA test, which was cleared for marketing by FDA in April 2007, the MRSA/SA test can provide results in less than an hour, Cepheid said.
 
“The ability to detect MRSA or SA in less than one hour, versus two to three days with current culture methods, will enable clinicians to make real-time decisions as to the best course of treatment or management,” Cepheid CEO John Bishop said in a statement.
 
Cepheid is working on a variety of tests for hospital-acquired infections, including C. difficile and vancomycin-resistant Enterococcus, which it hopes to launch next year. It also is developing tests for Factors II and V in hemostasis testing.
 
Bishop noted at last week’s UBS Global Life Sciences Conference that the firm would release study data on its C. difficile test at the end of October.
 
Shares of Cepheid were down 3.3 percent at $14.12 in early Monday trade on the Nasdaq.

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