Cepheid's Xpert™ MRSA PCR-Based Drug Resistant Test Receives FDA Clearance
News Apr 19, 2007
Cepheid has announced that it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert™ MRSA test, which runs on the GeneXpert® System, for the detection of Methicillin-resistant Staphylococcus aureus (MRSA).
Xpert MRSA results, delivered in over one hour, identify carriers of the potential pathogen and enable healthcare organizations to implement the proper infection control measures, leading to lower hospital acquired infection rates while improving patient care.
MRSA is a growing public health concern, and is cited as the leading cause of Hospital Acquired Infections (HAI's). According to the U.S. Centers for Disease Control and Prevention (CDC), HAI's number over 2 million annually, and that more than 100,000 hospital patients die each year as a result of contracting an infection while being treated for another condition.
Cepheid is currently engaged with a broad cross-section of healthcare organizations interested in initiating MRSA surveillance programs. These institutions are actively planning to initiate programs ranging from testing high-risk patients to testing all patient admissions.
"Currently there are multiple initiatives directed at reducing HAI's, especially those caused by MRSA," said Cepheid Chief Executive Officer John Bishop.
"The GeneXpert platform is uniquely positioned to aid hospitals currently doing molecular testing and hospitals considering initiating molecular testing. An additional benefit will be the ability of the GeneXpert system to provide reliable on-demand test information on a 24/7 basis. We expect to see the Xpert MRSA test play a critical role in active surveillance programs nationwide," he continued.
The Veterans Health Administration (VHA) is taking a leading role in improving policies to reduce MRSA infection.
In January 2007, it issued a directive requiring all VHA facilities to implement MRSA surveillance programs of all patients. While this directive does not mandate polymerase chain reaction (PCR) testing, it advises molecular based testing wherever feasible. Cepheid is currently working with VA hospitals across the country to potentially deploy Xpert MRSA in compliance with this directive.
"Patients that are potential carriers of MRSA are admitted to the hospital at all hours of the day and night," said David H. Persing, MD PhD, Chief Medical and Technology Officer, Cepheid. "But until now, the technology has not existed to provide MRSA STAT testing to enable real-time on-demand patient management decisions and reduce the spread of infection."