Meridian gets new clearance for bacterium test
Meridian Bioscience Inc. said Wednesday that it received clearance for a pediatric claim on its illumigene C. difficile test.
The test detects toxigenic strains of C. difficile, a bacterium that can cause diarrhea and colon inflammation. The company said the Food and Drug Administration gave the test a new clearance for use in patients who are younger than 2 years old. Before the company received the clearance, test results for young patients had to include a disclaimer that said the illumigene C. difficile test was not approved for use on patients under the age of 2.
Meridian said other tests do not have the clearance.
The FDA approved the illumigene C. difficile test in July. Meridian said the test is primarily run on older patients, but a significant number of patients are from children under the age of 2. It is designed to return results in less than an hour.
Shares of Meridian fell 8 cents to $21.41 on Wednesday, and were unchanged in aftermarket trading.