Diagnostics company Meridian Bioscience (NASDAQ: VIVO) has received federal regulatory clearance to begin selling a pediatric version of its C. difficile test.
C. difficile is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. In recent years, C. difficile infections have become more frequent, more severe and more difficult to treat, according to Mayo Clinic.
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.
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, according to the statement.
“This new pediatric indicator for illumigene C. difficile will provide our customers with a critical tool to help detect and manage this devastating infection in young children,” CEO Jack Kraeutler said.
In January, Meridian reported its fourth consecutive quarter of declining year-over-year earnings. First-quarter earnings for fiscal 2011 dropped 32 percent as demand fell for the company’s rapid flu tests in the absence of fears about swine flu.
