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Canada Regulators Approve Meridian's C. Difficile Assay

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Meridian Bioscience today announced that Health Canada has given an approved medical device license to its molecular amplification assay for Clostridium difficile.

The illumigene C. difficile assay detects the presence of the toxin-producing region from the bacterium and provides highly accurate results in under an hour, the Cincinnati-based company said in a statement. It added that the license announced today positions it in the Canadian market to "provide a full line of C. difficile testing solutions that meet the needs of its clinical lab customers."

The test was recently launched in the US, Australia, Taiwan, and most European markets.

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