The recent E. coli outbreak making headlines in Europe and the United States has been identified as a rare and unique strain, E. coli O104:H4. The outbreak strain is a Shiga toxin 2 type producing E. coli, and is of concern because initial lab findings have revealed various characteristics that make it more virulent and toxin producing. The most recent statistics show that 1,674 people have been infected with this strain across 13 European countries. 661 cases of HUS (Hemolytic Uremic Syndrome) and more than 16 deaths have been reported. The Centers for Disease Control and Prevention is also investigating four cases of HUS in the United States in patients that recently traveled to Germany. This outbreak highlights the need for rapid, accurate tests that detect all strains of Shiga toxin-producing E. coli, not just a test that detects E. coli O157:H7. An early, differentiated diagnosis is critical to improving patient outcomes. Antibiotics are contraindicated and should be avoided when treating a patient suffering from Shiga toxin-producing E. coli infection. Paul Granato, Ph.D., Director of Microbiology at Laboratory Alliance of Central New York, stated, "The outbreak of diarrheal disease caused by Shiga-toxin producing Escherichia coli O104:H4 that is occurring in various parts of Europe emphasizes the need for clinical microbiology laboratories to use a test method, such as commercially available enzyme immunoassay (EIA), that will detect the presence of non-O157:H7 strains of E. coli that are capable of producing Shiga-like toxins 1 and/or 2. We know that over 50% of Shiga-toxin producing E. coli diarrheal infections that occur in the United States and other parts of the world are caused by non-O157:H7 strains of E. coli. The use of traditional culture-based methods alone may have missed or significantly delayed the detection of the E. coli O104:H4 diarrheal pathogen thereby increasing its potential for causing hemolytic syndrome and other life-threatening complications. Currently, the only way clinical laboratories can reliably screen for all possible Shiga-toxin producing E. coli that are capable of causing this disease is by using an EIA method." Richard Eberly, Chief Commercial Officer stated, “Disease caused by E. coli can be devastating. Meridian Bioscience is prepared to support the testing needs of the global lab community in diagnosing Shiga toxin-producing E. coli with our Premier EHEC and Immuno Card STAT! EHEC products. It is our goal that the recommendations of the Centers for Disease Control (CDC) for diagnosing Shiga toxin-producing E. coli will become routine practice so that these serious infections can be detected quickly and appropriate therapies instituted.” 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.