Meridian Bioscience receives FDA clearance for new molecular pneumonia test

June 21, 2013

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.

The illumigene Mycoplasma test utilizes both throat and nasopharyngeal swab samples. The test procedure allows the flexibility of multiple specimen types and requires no expensive capital equipment. The test, which amplifies the specific DNA for the detection of Mycoplasma pneumoniae, relies upon a simple procedure that takes less than one hour. According to Meridian spokespersons, the technology is easy to use and cost-efficient, and leaves a small footprint. These factors, they assert, make it ideal for enabling a more rapid diagnosis, providing earlier identification of outbreaks and prevention of secondary cases through implementation of control measures. They compare the molecular test favorably to M. pneumoniae bacterial culture, in terms of both sensitivity and practicality, as the organism may take up to six weeks to culture.

John A. Kraeutler, Meridian Chief Executive Officer, states, “As a significant cause of community-acquired pneumonia, Mycoplasma pneumoniae is under-diagnosed and under-reported. With illumigene Mycoplasma, laboratories can offer healthcare providers fast, accurate information so that patients may receive a definitive diagnosis and rapid, appropriate antibiotic therapy.” He adds that illumigene Mycoplasma will be available for delivery to customers by the end of June. Read more product details.