Meridian Bioscience Receives FDA Clearance for New Premier (TM) C.
difficile GDH Assay
difficile GDH Assay
CINCINNATI, May 10, 2011 (BUSINESS WIRE) --
Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ:VIVO) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for a new Clostridium difficile immunoassay named Premier(TM) C. difficile GDH. This product expands the Company's existing portfolio of C. difficile tests and has been available in Europe and the rest of world since October of 2010. The assay detects a common antigen produced by toxigenic and non-toxigenic forms of C. difficile bacteria. Toxigenic forms of C. difficile are frequently associated with hospital and community acquired diarrhea resulting from antibiotic therapy and, in severe cases, can cause a life-threatening inflammation of the colon. Premier(TM) GDH is used by laboratories that want to screen patients with diarrhea for both forms of C. difficile. To differentiate those patients at risk of disease with toxin-producing forms of C. difficile, GDH-positive samples should be re-tested with toxin-detecting tests such as Meridian's Premier(TM) Toxins A&B or ImmunoCard(R) Toxins A&B, or with a molecular amplification assay, such as Meridian's illumigene(R)C. difficile test.
Jack Kraeutler, Chief Executive Officer, commented, "C. difficile can be a very dangerous infection that may lead to severe consequences for both patients and the healthcare institutions that care for them. Clearance of our new Premier(TM) C. difficile GDH test continues the Company's long history of breakthrough products for the detection and identification of C. difficile. Meridian introduced its first latex based assay in March, 1990. Shortly thereafter, Meridian scientists confirmed that the "latex-reactive protein" of C. difficile was in fact a glutamate dehydrogenase and not a toxin, as previously thought. Continuing innovation allowed Meridian to launch the first commercially available GDH enzyme immunoassay (ImmunoCard(R)C. difficile GDH) in January 1993 that was significantly more sensitive than the previous latex based tests. This third generation GDH assay, built on 20 years of C. difficile expertise, should set a new standard for GDH identification and, along with our toxin detection assays and our new illumigene(R) molecular platform, affirms our unique position as the one IVD Company that offers complete solutions for C. difficile detection."
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. 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 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 also 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 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 effects 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, veterinary testing 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.
SOURCE: Meridian Bioscience, Inc.
Meridian Bioscience, Inc.
John A. Kraeutler, Chief Executive Officer, 513-271-3700