Cepheid Gets Xpert Approval

Cepheid (CPHD - Analyst Report) has recently received approval of the U.S. Food and Drug Administration (FDA) for its Xpert C. Difficile test.

The Xpert C. Difficile test is the first on-demand molecular diagnostic test designed to detect Clostridium difficile infection (CDI) within just 45 minutes. The test runs on Cepheid's GeneXpert system and delivers quick turnaround with a high degree of accuracy.

Over past several years, CDI has turned out to be one of the most common healthcare-associated infections (HAI) in the United States. The disease induces mild to severe form of diarrhea, pseudomembranous colitis, toxic megacolon and sepsis -- and can even cause death. According to a study by the Association for Professionals in Infection Control and Epidemiology (APIC), there would be over 7,000 CDI patients in the United States on any given point -- out of which nearly 300 patients die every day.

Cepheid will start shipping the product from next week. Cepheid’s share opened up 4% at $8.81 on Tuesday. We maintain our Hold recommendation on the stock.

Read the full analyst report on CPHD