Meridian Bioscience announced that the U.S. Food and Drug Administration (FDA) has cleared its newly updated and simplified molecular diagnostic test for Mycoplasma pneumoniae, the cause of an infectious if mild form of pneumonia often called “walking pneumonia.”
The Illumigene Mycoplasma Direct assay was launched in Europe earlier this year, having received the CE Mark from the European Union. It is an improved version of a test cleared by the FDA in 2013. The assay consists of a simplified and easy three-step procedure that eliminates the need for specialized training, and provides definitive results in less than one hour.
The test utilizes throat swabs and requires less than two minutes of hands-on time to process. Its ability to accurately detect infection soon after symptoms appear also makes it less likely that broad spectrum antibiotics would be prescribed to people, limiting their likelihood of developing antimicrobial resistance.
“As the market share leader for Mycoplasma pneumoniae testing, we are pleased to be able to offer our customers an improved molecular assay for Mycoplasma pneumoniae. By simplifying the procedure of illumigene Mycoplasma we are able to address a larger customer base with a superior diagnostic tool that will dramatically improve patient care,” Mike Shaughnessy, executive vice president and president of Meridian Global Diagnostics, said in a news release. “Traditional methods of diagnosis include serology and X-Ray which may have as low as 25% and 41% sensitivity respectively, making rapid, targeted detection for specific treatment difficult. Our illumigene molecular platform does not require cumbersome capital equipment or costly hidden service contracts. We believe illumigene is the best value choice for molecular detection in infectious disease.”
The illumigene Mycoplasma Direct is now available for order in the U.S., as are other assays in the company’s portfolio, including tests for C. difficile, Group A Streptococcus, Group B Streptococcus, Herpes Simplex Virus type 1 & 2, pertussis, chlamydia, gonorrhea, and malaria.
According to the Centers for Disease Control and Prevention, between 1 and 10 out of every 50 cases of community-acquired pneumonia in the United States are caused by M. pneumoniae. The mild illness is especially common in children and young adults.