Meridian Bioscience Inc, Cincinnati, has received FDA clearance for a new molecular diagnostic test for Mycoplasma pneumonia (M. pneumoniae), its fourth assay on the illumigene platform.

MeridianOften referred to as “walking pneumonia”, M. pneumoniae has been associated with up to 40% of community-acquired pneumonias.

illumigene Mycoplasma, by amplifying the specific DNA for the detection of Mycoplasma pneumoniae,  provides a definitive result, thus helping to ensure that patients receive the appropriate antibiotic therapy in a timely manner. M. pneumoniae bacterial culture lacks sensitivity and is often impractical for patient management, as the organism may take as long as up to 6 weeks to culture.

This test is the fourth assay on the illumigene platform, and uses both throat and nasopharyngeal swab samples. The test procedure is 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 1 hour. The simplicity of this technology, along with its cost-efficiency, and small footprint, enables a more rapid diagnosis; providing earlier identification of outbreaks and prevention of secondary cases though implementation of control measures.

“As a significant cause of community-acquired pneumonia, Mycoplasma pneumoniae is under-diagnosed and under-reported,” says John A. Kraeutler, CEO, Meridian Bioscience. “With illumigene Mycoplasma, laboratories can offer health care providers fast, accurate information so that patients may receive a definitive diagnosis and rapid, appropriate antibiotic therapy.”

[Source: Meridian Bioscience]