New Molecular Test for C. Difficile From Meridian Bioscience Expected to Be Launched in Fiscal Year 2009
Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ: VIVO) today announced, in conjunction with the Association for Molecular Pathology 2008 Annual Meeting now occurring in Grapevine, Texas, that it anticipates launching a simple, rapid new molecular test for the toxin-producing forms of the C. difficile bacteria in the second half of fiscal year 2009. This innovative molecular test is based upon Loop Mediated Isothermal Amplification (LAMP) licensed by Meridian Bioscience from Eiken Chemicals, Ltd. (Japan) in 2006. Clostridium difficile is most common in hospitals and, recent hypervirulent forms of the bacteria have caused increased infection and mortality. C. difficile is carried in the gut of 3% of healthy humans but prevalence in hospital patients tends to be much higher. Elderly people in hospitals being treated with antibiotics are most at risk of developing infection.
The new “LAMP” C. difficile test has been in development for two years and is now completing beta site evaluations. Meridian has successfully completed its FDA pre-submission activities and expects to initiate clinical trials in January with a 510(k) application to follow within 90-120 days thereafter. International revenues are likely in the second half of Fiscal 2009, with U.S. sales to follow FDA clearance.
This new test is based upon the amplification of DNA from toxin-producing strains of the C. difficile bacteria. The procedure is remarkably simple, highly sensitive, and yields results in less than one hour. It requires no expensive capital equipment. The test relies upon a simple 3-step procedure that includes extraction, amplification and detection. The entire amplification is isothermal and results are read in a simple heater/reader. All reagents and disposables will be contained in the final kit package capable of room temperature storage. Meridian believes that the “point-of-care” simplicity of this technology, along with its cost efficient design, makes this innovative methodology ideal for helping to diagnose most acute infectious diseases, especially in those instances where there is a low level of the biological target.
Jack Kraeutler, Chief Executive Officer stated, “Our development of the “LAMP” technology has progressed to a point where we have achieved our goal of simplicity, speed, affordability and broad applicability. This technology will appeal to any size acute care laboratory that is seeking molecular amplification capability with no capital investment and, the ultimate in simplicity and accuracy. We are eager to complete our clinical trials and our subsequent FDA submission. We look forward to satisfying the needs of the infectious disease labs that have reacted so positively to our market research. We believe that today’s laboratories need a choice of rapid diagnostic testing methods. As we move ahead, I look forward to the expansion of the “LAMP” testing menu, as well as continuing to focus on developing rapid immunoassays, to satisfy best the needs of the acute care laboratory.”
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.