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FDA Clears BD's C. Difficile Test as IVD

NEW YORK (GenomeWeb News) — Becton Dickinson unit BD Diagnostics said yesterday that it has received 510(k) clearance from the US Food and Drug Administration to sell its molecular diagnostic test to identify the bacterium Clostridium difficile in the US.

The company's GeneOhm Cdiff test is a rapid stool test to identify the bug's Toxin B gene, which is found in toxigenic C. difficile bacteria.

"This test should improve patient care because it gives labs the option of a single assay that will markedly reduce or even eliminate the need for multiple screening and confirmatory tests," said Thomas Davis, who is a professor at Indiana University's School of Medicine and a pathologist at Wishard Health Services and Clarian Health.

"This would speed up reporting and help avoid unnecessary antibiotic use," Davis added.

An estimated 500,000 people in the US are infected with CDI each year, and over 28,000 of those die, the company said.

According to a survey by the Association for Professionals in Infection Control and Epidemiology, as many as 13 out of every 1,000 hospitalized patients are infected with CDI, and these infections may lead to $1 billion in excess healthcare costs in the US each year.

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