A Medical Device Daily

Molecular diagnostics maker Cepheid (Sunnyvale, California) reported that it received clearance from the FDA to market its Xpert MRSA test, which runs on the GeneXpert System, for the rapid detection of methicillin-resistant Staphylococcus aureus (MRSA).

Xpert MRSA results, designed to be delivered in just over one hour, are expected to rapidly identify carriers of the potential pathogen and enable healthcare organizations to implement the proper infection control measures, which is expected to lead to lower hospital acquired infection rates while improving patient care, the company said.

MRSA is a growing public health concern, and is cited as the leading cause of hospital-acquired infections (HAI's).

"Currently there are multiple initiatives directed at reducing HAI's, especially those caused by MRSA," said Cepheid CEO 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."

According to the Centers for Disease Control and Prevention (CDC), HAI's number more than 2 million annually, and more than 100,000 hospital patients die each year as a result of contracting an infection while being treated for another condition.

According to U.S. Congressional Record (H.R. Bill 1174), these HAI's contribute to more than $50 billion in annual medical costs, Cepheid said. MRSA infection rates have increased every year since 1970.

Cepheid said it is engaged with a "broad cross-section" of healthcare organizations interested in initiating MRSA surveillance programs. Those institutions are actively planning to initiate programs ranging from testing high-risk patients to testing all patient admissions, the company said.

The Veterans Health Administration (VHA) is taking a leading role in improving policies to reduce MRSA infection, the company said. In January, 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 Persing, MD, PhD, chief medical and technology officer of 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."

MRSA is a bacterium that is resistant to antibiotics including methicillin, oxacillin, penicillin and amoxicillin affecting those with weakened immune systems such as hospital patients and nursing home residents. When MRSA enters the body through the skin it can cause serious skin infections, and if it enters the bloodstream or lungs, it can cause critical blood infections, pneumonia and even death.

The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that the company said represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination.

The GeneXpert System is the only system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis.

The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has "a variety of configurations to meet the broad range of testing demands of any clinical environment," the company said.