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Meridian's C. Difficile MDx Assay Receives FDA Clearance

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared Meridian Bioscience's illumigene C. difficile molecular amplification assay, the company announced today.

In a statement, Cincinnati, Ohio-based Meridian said that the assay detects the presence of the toxin-producing region from the Clostridium difficile DNA and provides "highly accurate" results in less than an hour. The system allows for diagnosis of the disease with "high levels of sensitivity," and its "simple workflow requires minimal hands-on time per sample," the company said.

The illumigene C. difficile system was recently launched in Europe. Meridian submitted a 510(k) application with FDA for the test in March.

C. difficile is a bacterium that causes diarrhea and in extreme cases, life-threatening inflammation of the colon.

The test is the first molecular diagnostic product for Meridian, which makes diagnostic tests for gastrointestinal and upper respiratory infections, serology, parasitology, and fungal diseases. It is based on Meridian's loop amplification technology, which is isothermal and requires no costly capital equipment, according to the firm.