Devices & Diagnostics

Meridian Bioscience gets Canadian nod for rapid C. difficile test

Meridian Bioscience Inc. (NASDAQ:VIVO) has obtained a license to begin selling its illumigene C. difficile molecular test in Canada.

Meridian Bioscience Inc. (NASDAQ:VIVO)  has obtained a license to begin selling its illumigene C. difficile molecular test in Canada.

C. difficile is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. Meridian’s illumigene C. difficile test can detect the presence of the bacteria in a sample and deliver results within an hour, according to a statement from the Cincinnati-based company.

Meridian received approval to begin selling the device in the United States from the Food and Drug Administration in July. The test uses an amplification technology that makes it easier and less expensive to use than some other molecular tests in the fast-growing market for rapid test kits.

Meridian has experienced a rocky fiscal 2010, but expects to bounce back in 2011, CEO John Kraeutler said earlier this month. “In fiscal 2011, we expect to rebound from a very difficult fiscal 2010, a year in which we experienced a non-existent influenza season, competitive pressure in our C. difficile franchise and a challenging economy,” he said.

Kraeutler referred to his company’s traditional C. difficile test kits as being competitively challenged. Meridian’s new molecular platform of illumigene tests, starting with the one for C. diff., is supposed to push the company to the head of the competitive pack.