Meridian Bioscience, Inc. Receives FDA Clearance For New E. Coli Test
CINCINNATI--(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) to market ImmunoCard STAT!® EHEC, a revolutionary new test for the diagnosis of E. coli infection. The new product detects all Shiga-toxin producing E. coli and is the first rapid (20 minute) E. coli diagnostic that differentiates between Toxin 1 & Toxin 2.
With the recent national E. coli outbreaks (spinach in September 2006 and lettuce in December 2006), there has been an increased need in the hospital market for a highly accurate, quick, easy-to-use E. coli test. New CDC recommendations published in September 2006 recommend that laboratories use a test that detects all Shiga-toxin producing E. coli, not just a test that detects the O157 E. coli strain. ImmunoCard STAT!® EHEC, with its easy-to-perform procedure, provides a practical solution that will enable laboratories to adopt those new CDC recommendations.
ImmunoCard STAT!® EHEC is the first product resulting from a strategic partnership that was announced in August 2006 with the Performance & Life Science Chemicals Division of Merck KGaA, Darmstadt, Germany and its American company EMD. This new-to-the-world product introduction demonstrates the value of the long-term strategic partnership that has been formed.
John A. Kraeutler, President and Chief Operating Officer, stated, “Disease caused by E. coli can be devastating, particularly with children, and Meridian is proud to introduce an advanced method for rapid E. coli testing that will significantly improve patient care. The launch of ImmunoCard STAT!® EHEC further solidifies Meridian’s position as a leader in the field of E. coli testing.”
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.
Contacts
Meridian Bioscience, Inc. John A. Kraeutler, President, 513-271-3700