Meridian Bioscience, Inc. VIVO today announced that it has received
FDA clearance from the U.S. Food and Drug Administration for TRU
Legionella™, a new rapid assay for detection of legionellosis. TRU Legionella
is a rapid lateral flow device that provides optimized detection of Legionella
pneumophila serogroup 1 that is most commonly associated with Legionnaire's
disease. Suspected infection is characterized by non-specific upper
respiratory symptoms. The disease accounts for almost 100,000 cases per year
in the U.S., and it is estimated that 10,000 to 20,000 people are hospitalized
with Legionnaire's disease. However, many infections are not diagnosed due to
poor diagnostic options and these numbers may be higher.
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