Meridian Bioscience has received the US Food and Drug Administration (FDA) clearance for a new pediatric claim for its illumigene C difficile (Clostridium difficile) molecular amplification test.
The illumigene molecular test is designed to target the region of the C difficile DNA that is presented in all toxin A and/or toxin B producing strains.
The illumigene test provides accurate results in under an hour, for use on children under the age of two.
Meridian said the new test provides a high level of sensitivity, with a simple workflow requiring less than two minutes of hands-on time per sample.
Meridian CEO Jack Kraeutler said the new pediatric indicator for illumigene C difficile will provide their customers with a critical tool to help detect and manage the infection in young children.
"The early success of the illumigene technology, along with new claims and additional tests to be introduced in the near future using the illumigene technology, confirms our commitment to this unique molecular amplification technology," Kraeutler said.