Rapid Diagnostic Test for Mycoplasma pneumoniae Receives EU Mark of Approval

Rapid Diagnostic Test for Mycoplasma pneumoniae Receives EU Mark of Approval

Meridian Bioscience, Inc., recently announced that its new molecular diagnostic test for Mycoplasma pneumoniae, illumigene Mycoplasma Direct assay, has received the CE mark, which establishes that the product meet the European Union’s safety, health and environmental protection requirements. The test allows for a faster and definitive diagnosis, so  that patients affected by the bacteria may get appropriate and timely treatment.

M. pneumoniae is a bacterium that commonly causes respiratory system infections, especially chest colds in children. M. pneumoniae infection can also cause pneumonia, a more serious illness that, when caused by this bacteria, is often associated with atypical pneumonia (“walking pneumonia”), with different symptoms from pneumonia caused by common bacteria.

M. pneumoniae infection is often difficult to diagnose, as the bacterial culture lacks sensitivity and the organism can take up to six weeks to grow in the lab. According to the Centers for Disease Control and Prevention, estimates indicate that between 1 and 10 out of every 50 cases of community-acquired pneumonia in the United States is caused by M. pneumoniae.

The illumigene Mycoplasma Direct will allow the detection of the infection as soon as symptoms appear. It amplifies DNA from the bacteria, significantly improving the accuracy of the test. Moreover, the diagnostics test eliminates the need for specialized training and techniques, and provides results in less than one hour. As such, it will ensure that patients with M. pneumoniae infections receive timely antibiotic therapy, and it will help avoid the administration of broad spectrum antibiotics and the likelihood of antimicrobial resistance. The simple and cost-effective test uses throat swabs and requires only about two minutes of work.

“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,” Mike Shaughnessy, executive vice president and president of Meridian Global Diagnostics, said in a company news release.

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