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Cepheid Receives FDA Clearance for First On-Demand Diagnostic Test for Life-Threatening MRSA and Staphylococcus aureus From Patient Positive Blood Cultures
Date:10/1/2008

One Hour Test is Cepheid's Second FDA Cleared Diagnostic Test in 2008; Test Improves Time-to-Result by More Than Twenty-Four Hours Over Conventional

Methods

SUNNYVALE, Calif., Oct. 1 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(TM) MRSA/SA Blood Culture (BC) test, which runs on the GeneXpert(R) System, for the detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA, typically methicillin susceptible) in blood culture bottles showing gram-positive cocci -- in less than one hour.

Cepheid's Xpert MRSA/SA BC test processes positive blood culture specimens to determine if a patient's blood is infected with MRSA or SA, which are frequent causes of sepsis in hospitalized patients. This may enable physicians to quickly de-escalate from broad-spectrum antibiotic treatment to a more effective targeted therapy, thus reducing risk of resistance and improving patient outcomes. If the gram-positive cocci are neither MRSA nor SA, the physician may be able to stop antibiotics altogether.

"With the addition of our Xpert MRSA/SA Blood Culture diagnostic test, Cepheid is providing institutions with the most comprehensive product portfolio for rapid detection of MRSA and SA," said John Bishop, Cepheid's Chief Executive Officer. "The GeneXpert System is unique in its ability to combine the benefits of molecular testing with on-demand availability. In the case of sepsis, one of the ten leading causes of death in the United States, test results must be available quickly in order to have maximum impact."

According to a 22-year study published in the New England Journal of Medicine, the incidence of sepsis is growing at 8.7 percent annually in the U.S., expected to reach more than one million by 2010, while cases of severe sepsis account for up to 11 percent of ICU admission
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