Meridian Bioscience said this week that Health Canada has granted the company an approved medical device license for illumigene C. difficile, the company's Clostridium difficile molecular amplification assay.
The assay amplifies DNA using loop amplification technology to detect the presence of the toxin-producing region from the bacterium. Meridian said that the test provides highly accurate results in under an hour.
In July, Meridian received clearance from the US Food and Drug Administration to sell the test (PCR Insider, 7/15/2010). The company said it has also successfully launched the test in Australia, Taiwan, and most European markets.