Meridian Bioscience, Inc. has received the CE Mark for a new molecular diagnostic test for Mycoplasma pneumonia (M. pneumoniae). The new and improved illumigene Mycoplasma Direct assay features a simplified procedure compared to the existing illumigene Mycoplasma product. The new procedure will significantly expand Meridian’s customer base by eliminating the need for specialized techniques and training, as well as providing definitive results in less than one hour.

The launch of illumigene Mycoplasma Direct adds to the already robust illumigene menu that includes molecular tests for Group A Streptococcus, Pertussis, C. difficile, Chlamydia, Gonorrhea, HSV 1&2, Group B Streptococcus, and Malaria. All illumigene products are distributed in the EMEA regions by Meridian Bioscience Europe and in additional international markets by the Company’s global distribution network.

Mike Shaughnessy, Executive Vice President and President of Meridian Global Diagnostics stated, “We are excited to improve upon the only CE-marked and FDA-cleared stand-alone molecular assay for Mycoplasma pneumoniae (illumigene Mycoplasma). By simplifying the procedure we are able to provide more customers with a superior diagnostic tool that will improve patient care. Due to the lack of cell wall in Mycoplasma, typical antibiotics like penicillin and cephalosporin are not effective, making rapid, targeted detection for appropriate treatment of the utmost importance.”

illumigene Mycoplasma Direct is effective immediately as symptoms appear, by amplifying the specific DNA for the detection of active Mycoplasma pneumoniae infection. This represents a significant advancement in improving healthcare diagnoses and outcomes by providing a fast and definitive result, thus helping to ensure that patients receive the appropriate antibiotic therapy in a timely manner. M. pneumoniae bacterial culture lacks sensitivity and is often impractical for patient management as the organism may take as long as up to six weeks to culture. The ability to avoid treating patients empirically will reduce the administration of broad spectrum antibiotics and the likelihood of antimicrobial resistance.

The illumigene Mycoplasma test utilizes throat swabs and provides highly sensitive and specific results. It requires no expensive capital equipment or service contract. The test relies upon a simple procedure that takes less than two minutes of hands on time. The simplicity of this technology, along with its cost efficiency and small footprint, makes this innovative test ideal for enabling a more rapid diagnosis; providing earlier identification of outbreaks and prevention of secondary cases though implementation of control measures.