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 — Cepheid (Nasdaq: CPHD – News) 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® 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 admissions. The same study states that care of sepsis patients cost hospitals as much as $50,000 per patient, resulting in an annual healthcare burden of $17 billion.

Typically, physicians will order a set of blood culture bottles drawn from patients presenting with symptoms of systemic infections. Positive cultures can appear in as little as 6-24 hours, but then require further testing to identify the specific organism causing the infection. Currently, those additional tests — most notably to determine if the organism is methicillin-resistant or methicillin-susceptible Staphylococcus aureus — are done via slower culture testing methods.

“Same day diagnostic results for blood culture bottles growing gram-positive cocci will empower physicians to begin targeted therapy in septic patients far sooner than current culture-based methods,” said Dr. Ellen Jo Baron, Director of Clinical Microbiology Laboratories for Stanford University Hospital and Director of Medical Affairs at Cepheid. “These results, delivered 24-48 hours sooner, can potentially improve antibiotic stewardship and provide patients with the best, most effective therapeutic regimen.”

According to a Critical Care Medicine study, hospital costs associated with severe sepsis patients are 141 percent higher than those of other patients. The study also found that 72 percent of cases are under-reimbursed, and severe sepsis patients are five times as likely to be outliers.

Xpert MRSA/SA BC delivers on-demand test results to assist physicians in modifying patient treatment plans with targeted therapy to improve patient management, increase antimicrobial stewardship, and control treatment costs associated with the care of sepsis patients.