CINCINNATI--(BUSINESS WIRE)--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 STATEMENTS
The 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:
Meridian's continued growth depends, in part, on its ability to introduce into the marketplace enhancements of existing products or new products that incorporate technological advances, meet customer requirements and respond to products developed by Meridian's competition. While Meridian has introduced a number of internally developed products, there can be no assurance that it will be successful in the future in introducing such products on a timely basis. Meridian relies on proprietary, patented and licensed technologies, and the Company’s ability to protect its intellectual property rights, as well as potential for intellectual property litigation, would impact its results. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Recessionary pressures on the economy and the markets in which our customers operate, as well as adverse trends in buying patterns from customers can change expected results. Costs and difficulties in complying with laws and regulations, including those administered by the United States Food and Drug Administration, can result in unanticipated expenses and delays and interruptions to the sale of new and existing products. The international scope of Meridian’s operations, including changes in the relative strength or weakness of the U.S. dollar, can make results difficult to predict. One of Meridian's main growth strategies is the acquisition of companies and product lines. There can be no assurance that additional acquisitions will be consummated or that, if consummated, will be successful and the acquired businesses will be successfully integrated into Meridian's operations. There may be risks that acquisitions may disrupt operations and may pose potential difficulties in employee retention and there may be additional risks with respect to Meridian’s ability to recognize the benefits of acquisitions, including potential synergies and cost savings or the failure of acquisitions to achieve their plans and objectives. The Company cannot predict the possible impact of recently-enacted United States healthcare legislation and any similar initiatives in other countries on its results of operations. In addition to the factors described in this paragraph, Part I, Item 1A Risk Factors of our Form 10-K contains a list and description of uncertainties, risks and other matters that may affect the Company.
Meridian is a fully integrated life science company that manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products and diagnostic tests provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral and respiratory infections. Meridian’s diagnostic products are used outside of the human body and require little or no special equipment. The Company's products are designed to enhance patient well-being while reducing the total outcome costs of healthcare. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections, serology, parasitology and fungal disease diagnosis. In addition, Meridian is a supplier of rare reagents, specialty biologicals and related technologies used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products and technologies to hospitals, reference laboratories, research centers, diagnostics manufacturers and biotech companies in more than 60 countries around the world. The Company’s shares are traded through NASDAQ’s Global Select Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
Meridian Bioscience, Inc.
John A. Kraeutler, Chief Executive Officer, 513-271-3700