Diagnostics company Meridian Bioscience (NASDAQ: VIVO) has received U.S. Food and Drug Administration clearance for a new 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.
Cincinnati-based Meridian has several types of C. difficile tests on the market. The one that just received FDA clearance is called “Premier C. difficile GDH,” according to a statement from the company. It’s been available in Europe since October.
The newly cleared test detects a common antigen produced by toxigenic and non-toxigenic forms of C. difficile. It’s intended for use by laboratories that want to screen patients with diarrhea for both forms of C. difficile.
The toxic form of the bacteria is associated with hospital- and community-acquired diarrhea that results from antibiotic therapy, according to the statement.
Earlier this year, Meridian received FDA clearance on what it called the only C. difficile test on the market aimed at patients younger than 2 years old.
