FDA Clears Meridian Bioscience’s New Legionella Test

Meridian Bioscience, Inc. has announced that it has received FDA clearance from the U.S. Food and Drug Administration (FDA) for its TRU Legionella^TM test, a new rapid assay for the detection of legionellosis. The assay detects Legionella pneumophilia serogroup 1, the strain most commonly associated with Legionnaire’s disease.

Legionnaire’s disease accounts for almost 100,000 cases a year in the U.S., and it is estimated that 10,000 to 20,000 of these patients are hospitalized. Suspected infection is characterized by non-specific upper respiratory symptoms, however many infections are not diagnosed due to poor diagnostic options.

The TRU Legionella test provides a much needed solution for an often under-diagnosed disease. There are between 4 and 5 million cases of community acquired pneumonia each year in the U.S. and Legionella is implicated in 5-8% of the cases. TRU Legionella empowers laboratories with an accurate, cost effective, and rapid result for Legionella detection.

John A. Kraeutler, Chief Executive Officer, stated, “TRU Legionella is an important addition to our respiratory product portfolio given the prevalence of the disease. This new assay solidifies our position as a leader in rapid, accurate testing methods for infectious disease testing. TRU Legionella provides labs with a highly accurate tool that can speed the detection of an under-diagnosed pathogen enabling rapid treatment for the patient. TRU Legionella is in distribution, via Meridian Bioscience Europe, for our European customers.”