NEW YORK (GenomeWeb News) – Meridian Bioscience today announced the US Food and Drug Administration has cleared its illumigene C. difficile test for pediatric use.
The test is based on Meridian's loop amplification technology, which is isothermal and requires no costly capital equipment, and targets the region of the C. difficile DNA present in all toxin A and/or toxin B producing strains.
The FDA originally gave Meridian's molecular amplification test 510(k) clearance in July.
According to Meridian, the FDA action announced today makes its test the only one cleared by the agency for use on children under the age of two.
"As we monitored the C. difficile market, we recognized and acted upon the increasing prevalence of pediatric C. difficile in order to be able to address the growing needs of our clinical lab customers," Jake Kraeutler, CEO of Meridian, said in a statement. "This new pediatric indicator for illumigene C. difficile will provide our customers with a critical loop to help detect and manage this devastating infection in young children."