Meridian Bioscience, a manufacturer of immunoassay C difficile tests, has received an approved medical device license from Health Canada for its new molecular amplification assay, illumigene C difficile.

The illumigene molecular amplification assay detects the presence of the toxin producing region from the C difficile DNA, and provides accurate results in under an hour.

Meridian claims that the new illumigene C difficile molecular diagnostic system provides high levels of sensitivity for diagnosing the infectious disease and its simple workflow requires minimal hands-on time per sample and the product has been recently launched successfully in the US as well as in Australia, Taiwan and most European markets.

Meridian chief executive officer Jack Kraeutler said that toxin producing C difficile infections, especially in hospitalised patients, can have especially devastating consequences if not diagnosed and treated quickly.

“Because disease symptoms of C difficile infection can strike patients at any hour of the day or night, Meridian designed illumigene C difficile to enable real-time molecular testing in any lab at any time and with minimal hands-on time and virtually no capital expense, illumigene gives any infectious disease lab access to a convenient and powerful DNA amplification platform,” Kraeutler said.