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Cepheid Receives FDA Clearance for First Rapid On-Demand Molecular Diagnostic Test for MRSA and S. aureus
Date:9/29/2008

nt culture-based lab testing methods require 48-72 hours to determine if a skin or soft tissue infection is caused by MRSA or SA. As a result, physicians and surgeons often prescribe broad-spectrum antimicrobial therapies while awaiting culture results.

"Millions of patients visit emergency departments and urgent care clinics each year for treatment of 'staph' infections in skin and underlying tissue, many caused by MRSA. Because culture-based antibiotic test results are not available to physicians for several days, physicians have been forced to make decisions about wound drainage and antibiotic therapy without having the benefit of supportive laboratory data," said Dr. Donna Wolk, Division Chief of Clinical Microbiology, College of Medicine; and Research Associate, BIO5 Institute at The University of Arizona. "Our clinical trial data show that this new laboratory test makes it possible to accurately detect a staph infection before a patient is released, and it provides information to support treatment choices. In addition, the GeneXpert System supports informed antibiotic choices whereby prescribing antibiotics of last resort can be reserved for those patients truly infected with MRSA, therefore, reducing the chances of microbes further developing antibiotic resistance."

Community Acquired Infections in the ER & Healthcare Acquired Surgical Site Infections

MRSA and SA infections are national medical concerns that place millions of lives at risk and add millions of dollars to healthcare costs each year - both in outpatient, or community-acquired infections, and in-patient, or surgical site infections acquired within the healthcare environment.

The Centers for Disease Control recently reported that an estimated 12 million people in the United States seek outpatient medical attention each year for skin and soft tissue infections, of which MRSA plays a major role. Significant incremental healthcare costs associated with these infections are
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