The U.S. Food and Drug Administration (FDA) has approved molecular diagnostics company Cepheid (NASDAQ: CPHD)'s test designed to detect the toxin associated with a common bacterial infection that can cause diarrhea and other serious intestinal conditions and death in severe cases.
Clostridium difficile (C. difficile) bacteria are found in the stool of an infected person. Others can become infected if they touch items or surfaces contaminated with the bacteria or spores and then touch their mouth.
The Cepheid Xpert C. difficile/Epi assay is automated and works on the Cepheid GeneXpert Dx System to detect toxin gene sequences associated with toxigenic C. difficile. The Cepheid GeneXpert Dx System consists of an instrument that houses single-use disposable cartridges, a personal computer, and
software that allow a laboratory technician to run tests and view test results quickly.
The test, Cepheid Xpert C. difficile/Epi assay, determines if C. difficile is in a patient’s stool and also detects if the C. difficile is the epidemic 027/NAP1/BI strain, which has been associated with a marked increase in the severity and incidence of CDI in North America and Europe over the past decade, the U.S. health regulator said.
“Health care professionals in the infectious disease community who have seen various outbreaks of CDI associated with aggressive strains in recent years now have a new testing tool to detect this disease,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health.
Shares of California-based Cepheid ended Friday's regular trading at $29.25. In the past 52-weeks, the stock has been trading in the range of $13.81 to $30.07.