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Clostridium difficile test cleared

This article was originally published in The Gray Sheet

Executive Summary

BD's GeneOhm Cdiff molecular assay for rapid identification of toxigenic Clostridium difficile in stool specimens receives 510(k) clearance Jan. 12. Some 500,000 people in the U.S. suffer from Clostridium difficile infection each year, resulting in over 28,000 deaths, the firm says. The infection afflicts an estimated 13 of 1,000 hospitalized patients, increasing hospital stays and costs. The test could "markedly reduce or even eliminate the need for multiple screening or confirmatory tests," speeding up reporting and helping avoid unnecessary antibiotic use, says pathologist Thomas Davis, Indiana University School of Medicine
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