FDA approves new Clostridium difficile test

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The U.S. FDA has approved a test called the 'Cepheid Xpert

C. difficile/Epi assay' that is designed to rapidly detect

the toxin B gene associated with Clostridium difficile

infection (CDI), a cause of diarrhea that can lead to

colitis, other serious intestinal conditions and death in

severe cases.

People at risk of developing the infection include those who

are on antibiotics for other infections, the elderly, and

immunosuppressed patients in hospitals and nursing homes.

It has been known to effect CLL patients and can become a

chronic problem. Chronic CDI infection is estimated to occur

in perhaps 15-30% of those infected.

" 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, Ph.D., director of the Office of In Vitro

Diagnostics Device Evaluation and Safety in the FDA's Center

for Devices and Radiological Health.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm250498.htm

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http://tinyurl.com/42ajgr4

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