NEW YORK (GenomeWeb News) – Meridian Bioscience today announced the US Food and Drug Administration cleared its molecular diagnostic test for Mycoplasma pneumonia.
The test is the fourth cleared by FDA to run on the Cincinnati-based company's illumigene platform and follows FDA clearance of Meridian's C. difficile assay, Group B Streptococcus assay, and Group A Streptococcus assay. The M. pneumonia test amplifies specific DNA to detect the bacterium, providing a "definitive result" and ensuring patients receive appropriate treatment in a timely manner, Meridian said.
It added that bacterial culturing for M. pneumonia lacks sensitivity, and because the bacterium may take up to six weeks to culture, the method is "impractical for patient management."
M. pneumonia has been associated with up to 40 percent of community-acquired pneumonia and is most often associated with atypical pneumonia. An estimated 2 million cases of M. pneumonia infections and 100,000 pneumonia-related hospitalizations occur in the US each year, the company said.
Meridian CEO John Kraeutler said that the test will be available for delivery to customers by the end of the month, and told GenomeWeb Daily News in an email that the company expects to file for FDA clearance for its illumigene pertussis test in the fall.