Meridian Bioscience, Inc. (NASDAQ: VIVO) today announced that it has received FDA clearance from the U.S. Food and Drug Administration (FDA) 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.
The TRU Legionella test provides a much needed solution for an often under-diagnosed disease. Approximately 4 million to 5 million cases of community acquired pneumonia occur each year in the U.S. and Legionella is implicated in 5-8% of the cases. According to published statistics, incidence of Legionella cases has nearly tripled in the past decade and could be attributed to increase testing for disease. 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.”
FORWARD LOOKING STATEMENTSThe Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, which may be identified by words such as "estimates", "anticipates", "projects", "plans", "seeks", "may", "will", "expects", "intends", "believes", "should" and similar expressions or the negative versions thereof and which also may be identified by their context. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. The Company assumes no obligation to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized. These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ materially, including, without limitation, the following:
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