Meridian Bioscience announced that the company’s new, simplified, and rapid molecular diagnostic test for Mycoplasma pneumoniae has received the CE Mark, allowing for the product to be legally placed on the European market.
M. pneumoniae causes an infectious form of pneumonia, often referred to as “walking pneumonia” due to its mild symptoms that usually do not require hospitalization. It is also called atypical pneumonia because the disease is different from more serious cases of pneumonia caused by more typical bacteria. Nonetheless, M. pneumoniae infection induces symptoms such as headache, overall discomfort, fever, coughing, and sore throat, and is associated with up to 40 percent of community-acquired pneumonias.
Adding to an extensive list of illumigene molecular tests for Streptococcus, chlamydia, gonorrhea, herpes and malaria, among others, illumigene Mycoplasma Direct can provide definitive results in less than an hour, and is far more simple to use than the existing illumigene Mycoplasma assay.
“We are excited to improve upon the only CE-marked and FDA-cleared stand-alone molecular assay for Mycoplasma pneumoniae (illumigene Mycoplasma),” said Mike Shaughnessy, executive vice president and president of Meridian Global Diagnostics, in a press release. “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.”
The new test uses throat swabs to provide highly specific and sensitive results, allowing for quicker diagnosis, which helps liming the spread of the disease to others through rapid implementation of preventive measures. Furthermore, the company reported, by amplifying the DNA for the detection of M. pneumoniae infection, illumigene Mycoplasma Direct is effective and presents reliable results as soon as the symptoms appear.
Given that M. pneumoniae bacterial culture could take up to six weeks to provide results, patients are often treated empirically with broad spectrum antibiotics. The new illumigene Mycoplasma Direct might also improve healthcare, by ensuring that infected patients are given the appropriate antibiotic on time, decreasing the likelihood of antimicrobial resistance.