Meridian Bioscience, Inc. (NASDAQ:VIVO) today announced that its tests detect the deadly toxins produced by the recent outbreak strain E. coli O104:H4. E. coli O104:H4 is the novel shiga toxin-producing strain associated with a number of deaths in Europe. It has also caused hemolytic uremic syndrome (HUS) (a type of kidney failure) in hundreds of others. In the United States, one confirmed and three suspected cases of E. coli O104:H4 infections have been identified in persons who recently traveled to Germany. One case of HUS in Massachusetts has been confirmed as matching the German outbreak strain. Among the three suspected cases, two are cases of HUS, one case each in Michigan and Wisconsin. The third suspected case, a person with shiga toxin-positive diarrheal illness, is still under investigation. (See information posted to the CDC website.) Meridian has been able to conduct testing on clinical isolates from one of these clinical samples utilizing its two distinct tests for shiga toxin-producing E. coli (STEC) and confirmed that its tests have correctly identified the samples as shiga toxin-producing and, more specifically, that it produces shiga toxin-2. Shiga toxin-producing E. coli, or STEC, are common foodborne contaminants. It is the shiga toxins that the organisms produce, either shiga toxin 1 or shiga toxin 2, that cause serious complications in the infected person. The most commonly detected STEC strain in North America is O157:H7. Mike Loeffelholz, PhD, ABMM, Associate Professor in the Department of Pathology and Director of the Clinical Microbiology Laboratory at University of Texas Medical Branch in Galveston, TX states,, “Detection of E. coli O157:H7 alone will under-detect shiga toxin-producing strains of E. coli (STEC). A U.S. study showed that roughly half of STEC isolates from routine stool samples were non-O157 strains (Hedican et al. 2009. CID). It is estimated that approximately one third of all illnesses caused by STEC, including hemolytic uremic syndrome (HUS), is due to non-O157 strains (Mead et al. 1999. EID; Mellmann et al. 2008. EID). As the distribution of gene targets for shiga toxins 1 and 2 varies among O157 and non-O157 STEC (Hedican et al. 2009. CID; Kappeli et al. 2011. EID), it is important that diagnostic assays detect both toxins. Some studies indicate that shiga toxin 2 has a higher association with HUS (Friedrich et al. 2002. JID), so the ability of assays to differentiate between the two toxins may also be clinically relevant.” Meridian’s Premier ™ EHEC (cleared by the FDA in April of 1995) and Immuno Card STAT! ® EHEC (cleared by the FDA in February of 2007) assays detect both toxin types. Immuno Card STAT! ® EHEC provides an additional advantage in that the test differentiates between shiga toxin 1 and shiga toxin 2. Rapid identification of the toxin 2 type will enable physicians to immediately isolate and appropriately treat infected patients to reduce the likelihood for the development of HUS. As expected, the toxin produced by the deadly E. coli strain from Europe is detected by Meridian’s shiga toxin-detecting assays, Premier ™ EHEC and Immuno Card STAT! ® EHEC. Richard Eberly, Chief Commercial Officer, stated, “Meridian will continue to support global demands by ensuring these kits are available in all regions where they are needed to detect and control infection.” 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.