New Molecular Amplification Test: illumigene® Mycoplasma, FDA Cleared

Meridian Bioscience, Inc., has received FDA clearance for a new molecular diagnostic test for Mycoplasma pneumonia (M. pneumoniae), its fourth assay on the illumigene platform. This innovative test that aids in identifying an important respiratory pathogen is a strong addition to the illumigene platform.The illumigene Mycoplasma test is the fourth assay on the illumigene platform and utilizes both throat and nasopharyngeal swab samples. The test procedure is remarkably simple and highly sensitive, allowing the flexibility of multiple specimen types. It requires no expensive capital equipment. The test relies upon a simple procedure that takes less than one hour. 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.