Cepheid Receives FDA Clearance for First On-Demand Molecular Diagnostic Test for Clostridium difficile Infection
Cepheid (CPHD) Monday announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert C. difficile test, an on-demand molecular diagnostic test designed for 45-minute detection of the bacterium that causes Clostridium difficile infection or CDI.
The Xpert C. difficile test is the first test for CDI to deliver both rapid turnaround and a high degree of accuracy, the company said.
"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's Chicago Stritch School of Medicine.
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.
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests for genetic analysis in the clinical, industrial and biothreat markets.
Read more in the company's press release.
regarding the risk for the development of Clostridium difficile–associated diarrhea more than 2 months after completion of treatment with a prepackaged regimen of lansoprazole, amoxicillin, and clarithromycin tablets,” its reports.