NEW YORK (GenomeWeb) – Meridian Bioscience today announced that Health Canada has approved for marketing Meridian's molecular assays for Mycoplasma pneumonia and Bordetella pertussis on the company's illumigene platform.
The M. pneumonia test amplifies specific DNA to detect the bacterium and help patients receive appropriate treatment in a timely manner. The B. pertussis test similarly amplifies a specific DNA target to detect that bacterium. It uses nasopharyngeal swab samples and takes less than sixty minutes to report a result.
The US Food and Drug Administration cleared the pertussis test in March and the M. pneumonia test last June.
Somagen Diagnostics and Meridian inked a deal in 2008 to distribute Meridian's products in Canada, and Somagen President Elena LoCastro said in a statement today that the two illumigene tests are the first standalone mycoplasma and pertussis molecular assays to receive medical device license approval from Health Canada.
"The addition of the illumigene mycoplasma and pertussis products to the illumipro-10 test menu offers current illumipro-10 system users within our laboratories the opportunity to further enhance their workflow and efficiencies," she said. "In addition, the launch of these new products combined with the existing illumigene test menu offers an attractive solution for further growth and expansion of our installed system base in Canadian medical laboratories."