Meridian Bioscience Receives FDA Clearance for Two New Rapid Tests for the Detection of Influenza and Respiratory Syncytial Virus
CINCINNATI--(BUSINESS WIRE)--Nov. 26, 2007--Meridian Bioscience, Inc. (NASDAQ:VIVO) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market two new upper respiratory tests: TRU FLU(R) and TRU RSV(R). These tests are based upon a new rapid test technology that features improved safety and space savings. TRU FLU(R) detects both influenza A and influenza B while TRU RSV(R) detects for respiratory syncytial virus. These companion tests are ideal for the diagnosis of common upper respiratory diseases.
According to the Centers for Disease Control and Prevention (CDC), up to 60 million people in the United States will contract influenza this year. More that 200,000 people are likely to be hospitalized due to the disease and approximately 36,000 people die each year from influenza. RSV is a virus which also circulates during the same time period, and is the most common cause of severe respiratory illness in small children. Influenza and RSV tests are often run simultaneously on the same patient specimens. The rapid diagnosis of influenza offers physicians the ability to treat promptly patients with antiviral medications and to avoid the prescribing of antibiotics that have no effect on influenza or RSV.
John A. Kraeutler, President and Chief Operating Officer, stated, "Upper respiratory disease caused by pathogens such as influenza and RSV are of serious worldwide concern. Our new TRU products are designed to provide rapid, accurate results with additional safety benefits for the lab. These new tests, which will be available during the current quarter, are manufactured at Meridian's Cincinnati facility and are expected to improve profitability."
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 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 any forward-looking statements. 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. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Costs and difficulties in complying with laws and regulations 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. Changes in the relative strength or weakness of the U.S. dollar can change expected results. 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 successfully integrated into Meridian's operations. In addition to the factors described in this paragraph, Part I, Item 1A Risk Factors of our Form 10-K contains a list of uncertainties and risks that may affect the financial performance of 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, veterinary testing centers, physician offices, 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.
CONTACT: Meridian Bioscience, Inc.
John A. Kraeutler, President, 513-271-3700
SOURCE: Meridian Bioscience, Inc.