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Meridian Bioscience Receives FDA Clearance for New Campylobacter Test

^{Published on 2009-02-04 08:25:28, Last Modified on 2009-02-04 08:26:56 - Market Wire}
 

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 a new test for Campylobacter. Launched as PREMIER™ CAMPY, the rapid EIA test provides for optimized detection of Campylobacter infection, the most commonly diagnosed bacteria for food borne illness in the U.S. Approximately 20 million tests are conducted each year in the U.S. to detect the illness, which is usually caused by poorly cooked poultry.

There is a significant need for the PREMIER™ CAMPY test because it provides a solution to several concerns associated with culture testing, currently the most commonly practiced lab technique for detecting the campylobacter bacteria. With culture, there is a potential for reduction in sensitivity due to variable culturing procedures, specimen viability, and inhibitory antibiotics in culture media. PREMIER™ CAMPY dramatically reduces these concerns with a consistent EIA method that measures the antigen instead of the fragile bacteria in an environment that is less inhibitory than current culturing procedures.

John A. Kraeutler, Chief Executive Officer, stated, "PREMIER™ CAMPY is an important addition to our product portfolio given the prevalence of the disease. This new assay solidifies our position as a leader in rapid, accurate testing methods in food borne testing. PREMIER™ CAMPY, as well as our PREMIER™ and ImmunoCard STAT!^® tests for toxigenic E. coli, provide acute care labs with highly accurate tools that can speed the detection of important pathogens and enable more rapid treatment of the patient. PREMIER™ CAMPY is already in distribution via Meridian Bioscience Europe for the Company's European markets and was also recently approved for sale in Canada."

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 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 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, 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 ].