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Meridian Receives CE Marking for Two New Molecular Tests Targeting Chlamydia and Gonorrhea

Meridian Bioscience, Inc., Cincinnati, Ohio today announced that it has received the CE Mark for two new molecular diagnostic tests for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), the sixth and seventh assays on the illumigene® platform. Along with these two new assays, Meridian also received the CE Mark for an innovative, simple, fast and cost effective sample preparation system, M-prep™, that is designed to facilitate the isolation of Chlamydia and Gonorrhoeae from clinical samples. All three products will be distributed in the EMEA regions by Meridian Bioscience Europe and in additional international markets by the Company’s global distribution network.

"Finally, there is a molecular platform in the market place that can decentralize testing that is typically done in core reference laboratories, and can be done so in a cost effective manner,” said Mike Shaughnessy, Executive Vice President and President of Meridian Global Diagnostics. “Meridian expects these two new illumigene tests, along with the innovative M-Prep system, to be introduced to laboratories that haven’t had the opportunity previously to perform molecular testing, or are looking for improvements to their current testing platform. This will allow health-care providers truly to enable collection, testing, and treatment to occur on the same day.”

Chlamydia trachomatis and Neisseria gonorrhoeae are the most common bacterial sexually transmitted infections worldwide. The World Health Organization estimates that 92 million cases of C. trachomatis and 62 million new cases of N. gonorrhoeae infections occur annually. The European Centers for Disease Control and Prevention (ECDC) have reported that chlamydial infections doubled over the last ten years, and the rate of gonorrhea is also on the rise. When detected quickly, both are easy to treat and manage. However, the issue occurs when older technologies are used for diagnosis, increasing time to treatment, causing patients and their partners to be uninformed and untreated.

The illumigene CT & NG assays utilize endocervical swabs, self-collected vaginal swabs, and female and male urine, making collection easy and non-invasive for physicians and patients. The test procedure is universal for all specimen types, and takes less than one hour to report a final result. Unlike other molecular systems, the illumigene platform requires no expensive capital equipment, and no costly annual service contracts. The performance and simplicity of this technology, along with its cost efficiency and small footprint, makes these new assays ideal for enabling a more rapid diagnosis.

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