MedCity News’ Brandon Glenn breaks down the recent FDA approval of Meridian Bioscience’s pediatric version of its C. difficile test on this week’s edition of Health Journal on ONN.
Meridian said its new product is the only C. difficile test that the U.S. Food and Drug Administration has cleared for use on children under the age of 2, according to a statement from the Cincinnati-area company.
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An earlier version of the test, which the company calls the “illumigene,” was cleared for commercialization by the FDA in July. However, that clearance didn’t apply to children.
The test provides results within an hour and requires about two minutes of hands-on time per sample.
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- Meridian Bioscience gets FDA OK on pediatric C. difficile test (medcitynews.com)