Meridian Bioscience Receives FDA Clearance For Two New Rapid Tests For The Detection Of Influenza And Respiratory Syncytial Virus

30 November, 2011 (00:00) | Home Insurance | By: admin

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Meridian Bioscience, Inc. (NASDAQ:VIVO) announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market two new upper respiratory tests: TRU FLU? and TRU RSV?. These tests are based upon a new rapid test technology that features improved safety and space savings. TRU FLU? detects each influenza A and influenza B while TRU RSV? 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 folks inside the United States will contract influenza this year. More that 200,000 folks are most likely to be hospitalized due to the illness and approximately 36,000 people die each year from influenza. RSV is actually a virus which also circulates during exactly the same time period, and is the most widespread trigger of severe respiratory illness in small kids. 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 illness caused by pathogens such as influenza and RSV are of serious worldwide concern. Our new TRU products are designed to give rapid, accurate results with additional safety benefits for the lab. These new tests, which will likely be obtainable during the existing quarter, are manufactured at Meridian and are expected to improve profitability.”

About Meridian Bioscience

Meridian can be 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 give accuracy, simplicity and speed in the early diagnosis and treatment of frequent 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 whilst reducing the total outcome costs of healthcare. Meridian has strong market positions inside 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 utilized by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products and technologies to hospitals, reference laboratories, investigation centers, veterinary testing centers, physician offices, diagnostics manufacturers and biotech companies in a lot more than 60 countries around the world. The Company’s shares are traded through NASDAQ’s Global Select Market, symbol VIVO. Meridian’s web site address is http://www.meridianbioscience.com.

Forward Looking Statements

The Private Securities Litigation Reform Act of 1995 offers a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical info, this report contains forward-looking statements which could 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 existing 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 trigger actual outcomes to differ materially, such as, 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 needs 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’ll be successful within the future in introducing such products on a timely basis. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may trigger 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 inside the relative strength or weakness of the U.S. dollar can change expected outcomes. One of Meridian’s main growth strategies is the acquisition of companies and product lines. There can be no assurance that additional acquisitions is going to 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 possibly affect the financial performance of the Company.

Meridian Bioscience