E. coli O104 Outbreak Highlights Need for Rapid, Accurate Testing Options

Cincinnati – 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 ImmunoCard 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.”

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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.

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