Xpert C. difficile Test Establishes New Benchmarks for Speed and Accuracy, Addressing Major Deficiencies In Previously Available Tests

SUNNYVALE, Calif., July 13 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(R) C. difficile test, an on-demand molecular diagnostic test designed for 45-minute detection of the bacterium that causes Clostridium difficile infection (CDI). The Xpert C. difficile test is the first test for CDI to deliver both rapid turnaround and a high degree of accuracy.

'The previous lack of an accurate and rapid diagnostic test for CDI has greatly impeded our ability to halt the increasing rate of CDI, which has taken a severe turn in the past several years. Patients can have their first diarrhea symptoms on a Monday and be dead by Thursday,' said Dale Gerding, MD, professor of medicine, division of infectious diseases, Loyola University Chicago Stritch School of Medicine. 'Toxigenic culture offers high sensitivity, but laboratories find it burdensome and far too slow for practical diagnostic use. Instead, many use less labor-intensive toxin EIA (enzyme immunoassay) and GDH (glutamate dehydrogenase) tests, which fail to detect 20-50% of cases. From a practical standpoint, this means many patients are not subjected to proper isolation procedures that can curtail transmission of C. difficile. A rapid, accurate CDI test will eliminate needless repetitive testing and enable us to implement appropriate treatment and infection control measures faster in our battle against this devastating Healthcare Associated Infection.'

C. difficile, a spore-forming bacterium, is now challenging Methicillin-resistant Staphylococcus aureus (MRSA) as the most prevalent Healthcare Associated Infection (HAI) in the United States. A recent study published by the Association for Professionals in Infection Control and Epidemiology (APIC) found that on any given day there are more than 7,000 patients in the United States suffering from CDI, causing the deaths of approximately 300 patients per day. The disease, which can range in severity from mild to severe diarrhea, pseudomembranous colitis, toxic megacolon, sepsis, and death, is costing American healthcare institutions up to $51.5 million per day.

'As the leader in molecular HAI testing, it is incumbent for Cepheid to provide healthcare institutions access to the most comprehensive suite of rapid and accurate HAI tests on the market. The Xpert C.