Fourth ‘Moderate Complexity’ Categorization Highlights GeneXpert(R) System Ease-of-Use

SUNNYVALE, Calif., Nov. 4 — Cepheid (Nasdaq: CPHD – News) today announced the U.S. Food & Drug Administration (FDA) categorized Cepheid’s Xpert(TM) MRSA/SA Blood Culture (BC) test as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments (CLIA). The new test is designed for on-demand detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA), (typically Methicillin-sensitive) in positive patient blood culture bottles.

Cleared by the FDA for marketing last month, Xpert MRSA/SA BC is the first molecular diagnostic test for positive blood culture bottles to receive the moderate complexity CLIA categorization. The test runs on Cepheid’s GeneXpert® System, the leading platform for on-demand detection of Healthcare Acquired Infections (HAIs).

“Cepheid is providing institutions with the most comprehensive product portfolio for rapid detection of MRSA and SA — all of which are now categorized ‘Moderate Complexity’ by the FDA,” said Cepheid Chief Executive Officer John Bishop. “The GeneXpert System is unparalleled in its ability to combine the benefits of molecular testing with on-demand availability. With ‘Moderate Complexity’ categorization, Xpert MRSA/SA BC can now be run 24/7.”

Xpert MRSA/SA BC 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.

Typically, physicians will order a set of blood culture bottles drawn from patients presenting with symptoms of systemic infections. While positive cultures can appear in as little as 6-24 hours, they require further additional 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.