Meridian Receives FDA Clearance
News Jun 21, 2016
Meridian Bioscience, Inc. has announced that it has received FDA clearance for a new molecular diagnostic test for Mycoplasma pneumonia (M. pneumoniae). The new and improved illumigene® Mycoplasma Direct assay, launched earlier this year in Europe, features a simplified 3-step procedure. 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.
Often referred to as “walking pneumonia”, M. pneumoniae is associated with up to 40% of community-acquired pneumonias and accounts for approximately two million infections annually in the United States. Due to the lack of cell wall in Mycoplasma, typical antibiotics like penicillin and cephalosporin are not effective. illumigene Mycoplasma Direct accurately detects infection on the first day of symptoms and provides the ability to avoid treating patients empirically to reduce the administration of broad spectrum antibiotics and the likelihood of antimicrobial resistance.
The illumigene Mycoplasma Direct test utilizes throat swabs and provides highly sensitive and specific results. It requires no expensive capital equipment or service contracts. The test relies upon a simple 3-step 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.
Mike Shaughnessy, Executive Vice President and President of Meridian Global Diagnostics stated, “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. 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.”
illumigene Mycoplasma Direct, now available for order immediately in the U.S., adds to the already broad illumigene menu that includes molecular assays for C. difficile, Group A Streptococcus, Group B Streptococcus, HSV 1&2 and Pertussis in the United States as well as Chlamydia, Gonorrhea and Malaria outside of the U.S.