FDA Clearance for New illumigene™ C.difficile

Meridian Bioscience, Inc., has received clearance from the FDA for its new molecular amplification assay, illumigene™ C.difficile.

The illumigene molecular amplification assay detects the presence of the toxin producing region from C. difficile DNA, and provides highly accurate results in under an hour.

The new illumigene™ C.difficile molecular diagnostic system provides high levels of sensitivity for diagnosing this serious, infectious disease. Its simple workflow requires minimal hands-on time per sample. The product has been recently launched successfully in Europe.

Jack Kraeutler, Chief Executive Officer, commented, 'Some years ago, Meridian recognized that our infectious disease lab customers may require molecular amplification capabilities in specific instances. Our goal has been to deliver the power of molecular amplification in a platform that is simple, highly cost effective, and accessible for any of our lab customers. With the introduction of illumigene™ C.difficile, we have achieved the first step towards that goal. We look forward to the success of illumigene C. difficile, and we will be expanding the test menu for this exciting new platform.'